Pilling Weck Surgical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pilling Weck Surgical” (first 1998, latest 2000), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 128 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DXC | Clamp, Vascular | 1 | 1 |
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
| KNQ | Dilator, Esophageal | 1 | 1 |
| MWS | Stabilizer, Heart | 1 | 1 |
Review panels
Most recent Pilling Weck Surgical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | MWS | 2000-09-13 | 415 |
| K992174 | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP | DXC | 2000-03-23 | 269 |
| K990935 | JACKSON ESOPHAGEAL DILATOR | KNQ | 1999-05-17 | 59 |
| K990561 | OPTICAL FORCEPS | JEK | 1999-05-14 | 81 |
| K982128 | SHIKANI-FRENCH SPEAKING VALVE | JOH | 1998-10-23 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Pilling Weck Surgical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pilling Co. (40 510(k)s)
- Pilling Weck, Inc. (6 510(k)s)
- Pilling Weck Group (5 510(k)s)
- Pilling Medical S.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pilling Weck Surgical?
FDA lists 5 510(k) clearances under the applicant name “Pilling Weck Surgical” (first 1998, latest 2000), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pilling Weck Surgical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pilling Weck Surgical is 128 days.
Which FDA product codes appear under Pilling Weck Surgical?
The most frequent FDA product codes under this applicant name are DXC (Clamp, Vascular, 1); JEK (Forceps, Biopsy, Bronchoscope (Rigid), 1); JOH (Tube Tracheostomy And Tube Cuff, 1).
Next steps
- See all 5 Pilling Weck Surgical clearances with predicates and recalls
- Run predicate analysis for product code DXC, Pilling Weck Surgical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.