Edward Weck, Inc.: FDA clearances and approvals
Edward Weck, Inc. has 140 FDA 510(k) clearances (first 1976, latest 1992), across 63 product codes in 10 review panels. Median 510(k) review time: 21 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | 14 | 14 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| FZP | Clip, Implantable | 7 | 7 |
| FZT | Cutter, Surgical | 5 | 5 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 5 | 5 |
| GEN | Forceps, General & Plastic Surgery | 5 | 5 |
| GAD | Retractor | 4 | 4 |
| GDO | Applier, Surgical, Clip | 4 | 4 |
| HND | Spatula, Ophthalmic | 4 | 4 |
| HNQ | Hook, Ophthalmic | 4 | 4 |
Plus 53 more product codes.
Review panels
- General and Plastic Surgery (69)
- Ophthalmic (33)
- Ear, Nose and Throat (17)
- Cardiovascular (5)
- Neurology (5)
- Obstetrics and Gynecology (4)
- General Hospital (3)
- Orthopedic (2)
- Gastroenterology and Urology (1)
- Microbiology (1)
Most recent Edward Weck, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915378 | WECK TROCAR | HET | 1992-06-29 | 213 |
| K914690 | LM15(TM), CATALOG NUMBER - 523821 | GCJ | 1992-03-23 | 157 |
| K911915 | HEMOCLIP II | FZP | 1992-01-09 | 254 |
| K914470 | PNEUMO-SEAL(TM) | GCJ | 1991-11-29 | 53 |
| K911272 | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 | FHG | 1991-07-02 | 102 |
| K902108 | HEM-O-LOK(TM) | FZP | 1990-08-06 | 90 |
| K902232 | WECK ELECTROSURGICAL GENERATOR #174200 | GEI | 1990-08-02 | 77 |
| K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 | JOJ | 1990-02-15 | 58 |
| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | DSY | 1987-08-27 | 161 |
| K851251 | AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 | FZP | 1985-07-02 | 97 |
130 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Edward Weck, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Edward Weck, Inc. have?
Edward Weck, Inc. has 140 FDA 510(k) clearances (first 1976, latest 1992), across 63 product codes in 10 review panels.
How long does FDA take to clear Edward Weck, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Edward Weck, Inc.'s cleared 510(k)s is 21 days.
What devices does Edward Weck, Inc. make?
Its most frequent FDA product codes are HNR (Forceps, Ophthalmic, 14); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 8); FZP (Clip, Implantable, 7).
Has Edward Weck, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Edward Weck, Inc. Related entities may recall under other names.
Next steps
- See all 140 Edward Weck, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNR, Edward Weck, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.