Pilling Weck Group: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pilling Weck Group” (first 1996, latest 1997), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Review panels
Most recent Pilling Weck Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971334 | PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR | GCJ | 1997-06-11 | 62 |
| K965176 | PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS | OCZ | 1997-03-04 | 70 |
| K964450 | SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT | HET | 1997-01-10 | 65 |
| K964123 | REUSABLE TROCAR WITH SLEEVE (COMMON) | GCJ | 1996-12-12 | 58 |
| K963815 | REUSABLE TROCAR WITH SLEEVE (COMMON) | GCJ | 1996-11-05 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Pilling Weck Group.
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 Surgical (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 Group?
FDA lists 5 510(k) clearances under the applicant name “Pilling Weck Group” (first 1996, latest 1997), across 3 product codes in 3 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 Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pilling Weck Group is 62 days.
Which FDA product codes appear under Pilling Weck Group?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); HET (Laparoscope, Gynecologic (And Accessories), 1); OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered, 1).
Next steps
- See all 5 Pilling Weck Group clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Pilling Weck Group'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.