FDA product code · Unknown
EFQGauze/Sponge, Internal
Product code EFQ covers Gauze/Sponge, Internal, a Class U device. FDA has cleared 271 devices in this code. Median review time across the 271 most recent decisions is 39 days. openFDA lists 13 recall records against this code.
Updated · ingest status · JSON
- Class
- Class U
- Regulation
- —
- Review panel
- Unknown
- Clearances
- 271
What is happening in EFQ right now?
EFQ (Gauze/Sponge, Internal) has one finding. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2458-2026, Z-2459-2026, Z-2639-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2458-2026, Z-2459-2026, Z-2639-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in EFQ?
FDA has cleared 271 devices under product code EFQ since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991757 | NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE | Furlong Industries | |
| K991215 | SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S | Symtex Healthcare Corp. | |
| K990974 | VITOP DRESSING | Wonder & Bioenergy Hi-Tech America, Inc. | |
| K990584 | GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE | Broadline Medical Industries | |
| K984187 | CROSSTEX NON-WOVEN SPONGES | Crosstex Intl. | |
| K983016 | GAUZE, SPONGES, CAT # 11-003 | Vitalcare Group, Inc. | |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dynarex Corp. | |
| K983450 | STARRYSHINE GAUZE SPONGE | T.C. Dental Products, Inc. | |
| K982648 | JOAN II | Celanese Acetate Co. | |
| K980791 | DUMEX PAK-ITS WOVEN RIBBON PACKING | Dumex Medical Surgical Products, Ltd. |
How long does FDA review take for EFQ?
The median FDA review time for EFQ is 39 days, measured across the 271 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EFQ?
openFDA lists 13 recall records against product code EFQ. A recall record covers one firm's corrective action and may span many device lots.
Z-2458-2026Open, ClassifiedAMD Medicom Inc.
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Z-2459-2026Open, ClassifiedAMD Medicom Inc.
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Z-2639-2026Open, ClassifiedTeleflex, Inc.
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Z-0772-2023Open, ClassifiedTeleflex, Inc.
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
Z-1118-2022TerminatedSteris Corporation
Product not approved for release for US distribution
Showing the 5 most recently initiated of 13. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EFQ?
MAUDE holds 66 adverse-event reports naming product code EFQ, 18 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in EFQ unusual?
Every month with enough history behind it falls inside EFQ's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | 0–18 | Within expected (0–18) | |
| 2 | 0–16 | Within expected (0–16) | |
| 1 | 0–17 | Within expected (0–17) | |
| 2 | 0–19 | Within expected (0–19) | |
| 3 | 0–16 | Within expected (0–16) | |
| 3 | 0–18 | Within expected (0–18) |
17 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in EFQ.
What are the predicate devices in EFQ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EFQ?
Across the 271 most recent decisions, these applicants filed most often in EFQ.
| Applicant | Recent clearances |
|---|---|
| Mcneil Healthcare, Inc. | 14 |
| Ormed Mfg., Inc. | 14 |
| American Medical Disposable, Inc. | 13 |
| Ritmed, Inc. | 10 |
| Certified Safety Mfg., Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch EFQ
Get an email the morning anything changes in EFQ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.