Medical device manufacturer
Edward Weck, Inc.
Edward Weck, Inc. holds 140 FDA 510(k) clearances across 63 product codes. Median elapsed review time is 21 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 140
- Product codes
- 63
- Median review
- 21 days
- Recall records
- 0
How does FDA spell Edward Weck, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Edward Weck, Inc. file in?
63 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HNR | Forceps, Ophthalmic | 14 | 7 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 50 days | |
| FZP | Clip, Implantable | 7 | 120 days | |
| FZT | Cutter, Surgical | 5 | 22 days | |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 5 | 7 days | |
| GEN | Forceps, General & Plastic Surgery | 5 | 16 days | |
| GAD | Retractor | 4 | 10 days | |
| GDO | Applier, Surgical, Clip | 4 | 6 days | |
| HND | Spatula, Ophthalmic | 4 | 9 days | |
| HNQ | Hook, Ophthalmic | 4 | 8 days | |
| KAE | Forceps, Ent | 4 | 21 days | |
| DWS | Instruments, Surgical, Cardiovascular | 3 | 9 days | |
| EPY | Speculum, Ent | 3 | 21 days | |
| FSM | Tray, Surgical, Instrument | 3 | 19 days | |
| GDG | Hook, Surgical, General & Plastic Surgery | 3 | 10 days | |
| GDT | Staple, Removable (Skin) | 3 | 42 days | |
| HAO | Instrument, Surgical, Non-Powered | 3 | 10 days | |
| KDG | Chisel (Osteotome) | 3 | 72 days | |
| FZI | Apparatus, Air Handling, Enclosure | 2 | 72 days | |
| GAG | Stapler, Surgical | 2 | 24 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 53 days | |
| HAM | Apparatus, Electrosurgical | 2 | 14 days | |
| HCH | Clip, Aneurysm | 2 | 18 days | |
| HNN | Knife, Ophthalmic | 2 | 9 days | |
| JYL | Hook, Microsurgical Ear | 2 | 6 days |
Showing the 25 they file in most, of 63.
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 Edward Weck, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Edward Weck, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K915378 | WECK TROCAR | HET | 213 | |
| K914690 | LM15(TM), CATALOG NUMBER - 523821 | GCJ | 157 | |
| K911915 | HEMOCLIP II | FZP | 254 | |
| K914470 | PNEUMO-SEAL(TM) | GCJ | 53 | |
| K911272 | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 | FHG | 102 | |
| K902108 | HEM-O-LOK(TM) | FZP | 90 | |
| K902232 | WECK ELECTROSURGICAL GENERATOR #174200 | GEI | 77 | |
| K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 | JOJ | 58 | |
| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | DSY | 161 | |
| K851251 | AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 | FZP | 97 |
Source: openFDA device/510k · retrieved
Watch what Edward Weck, Inc. files next
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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.