Medical device manufacturer
United States Surgical, A Division of Tyco Healthc
United States Surgical, A Division of Tyco Healthc holds 218 FDA 510(k) clearances across 66 product codes. Median elapsed review time is 70 days. openFDA lists 23 recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 218
- Product codes
- 66
- Median review
- 70 days
- Recall records
- 23
How does FDA spell United States Surgical, A Division of Tyco Healthc?
FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| United States Surgical | device/recall | normalised |
| United States Surgical Corporation | device/recall | normalised |
| United States Surgical, A Division of Tyco Healthc | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does United States Surgical, A Division of Tyco Healthc file in?
66 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 30 | 75 days | |
| GDW | Staple, Implantable | 28 | 58 days | |
| FZP | Clip, Implantable | 17 | 71 days | |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 12 | 63 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 9 | 105 days | |
| HAO | Instrument, Surgical, Non-Powered | 7 | 30 days | |
| FTL | Mesh, Surgical, Polymeric | 5 | 105 days | |
| GAP | Suture, Nonabsorbable, Silk | 5 | 47 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 27 days | |
| HRX | Arthroscope | 5 | 175 days | |
| GAL | Suture, Absorbable, Natural | 4 | 89 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 49 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 4 | 76 days | |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 3 | 90 days | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 | 70 days | |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 3 | 90 days | |
| GDH | Gouge, Surgical, General & Plastic Surgery | 3 | 17 days | |
| KNW | Instrument, Biopsy | 3 | 87 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 49 days | |
| LRC | Instrument, Ent Manual Surgical | 3 | 40 days | |
| OCW | Endoscopic Tissue Approximation Device | 3 | 51 days | |
| DXC | Clamp, Vascular | 2 | 82 days | |
| FBQ | Trocar, Gastro-Urology | 2 | 66 days | |
| FHM | Apparatus, Suturing, Stomach And Intestinal | 2 | 24 days | |
| GAG | Stapler, Surgical | 2 | 101 days |
Showing the 25 they file in most, of 66.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has United States Surgical, A Division of Tyco Healthc had a recall?
openFDA lists 23 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1148-06TerminatedFOZ
The 9F device may contain a 10 F sheath instead of the 9F
Z-1149-06TerminatedFOZ
The 9F device may contain a 10 F sheath instead of the 9F
Z-1150-06TerminatedFOZ
The 9F device may contain a 10 F sheath instead of the 9F
Z-1151-06TerminatedFOZ
The 9F device may contain a 10 F sheath instead of the 9F
Z-1152-06TerminatedFOZ
The 9F device may contain a 10 F sheath instead of the 9F
Showing the 5 most recently initiated of 23.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has United States Surgical, A Division of Tyco Healthc cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K071406 | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER | FZP | 184 | |
| K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR | GDW | 78 | |
| K061288 | AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER | FZP | 177 | |
| K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | GDW | 28 | |
| K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | GCJ | 23 | |
| K061095 | AUTO SUTUR ENDO GIA STAPLERS | GDW | 42 | |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | GAW | 47 | |
| K042412 | MODIFIED SPACEMAKER SYSTEM | GCJ | 17 | |
| K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM | HWC | 23 | |
| K032696 | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT | GDW | 90 |
Source: openFDA device/510k · retrieved
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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.