Wilson Greatbatch Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Wilson Greatbatch Technologies, Inc.” (first 1994, latest 1998), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 200 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 | 4 | 4 |
| CCW | Laryngoscope, Rigid | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- General and Plastic Surgery (4)
- Anesthesiology (2)
- Ear, Nose and Throat (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent Wilson Greatbatch Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971374 | GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE | HIH | 1998-05-13 | 394 |
| K971377 | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | CCW | 1998-04-30 | 381 |
| K972280 | GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES | GCJ | 1997-12-11 | 176 |
| K971781 | GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES | HRX | 1997-11-21 | 191 |
| K970619 | GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE | CCW | 1997-11-19 | 274 |
| K971375 | GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE | EOB | 1997-10-31 | 200 |
| K954649 | WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP | GCJ | 1995-12-22 | 73 |
| K950063 | WGL ENDOSCOPIC GRASPER* | GCJ | 1995-01-27 | 21 |
| K942168 | WGL ENDOSCOPIC GRASPER | GCJ | 1994-12-13 | 223 |
Recalls
openFDA lists no recalls under a recalling firm named Wilson Greatbatch Technologies, Inc..
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.
- Wilson Biomedical, Inc. (2 510(k)s)
- Wilson Glove Products Co., Ltd. (2 510(k)s)
- Wilson Instruments (Shanghai) Company Limited (2 510(k)s)
- Wilson Cook Medical (1 510(k)s)
- Wilson Hunt Intl./, Ltd. (1 510(k)s)
- Wilson Instruments (Sha) Co., Ltd. (1 510(k)s)
- Wilson Medical Instruments Co. (1 510(k)s)
- Wilson Tech (International) Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wilson Greatbatch Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Wilson Greatbatch Technologies, Inc.” (first 1994, latest 1998), across 5 product codes in 5 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 Wilson Greatbatch Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wilson Greatbatch Technologies, Inc. is 200 days.
Which FDA product codes appear under Wilson Greatbatch Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 4); CCW (Laryngoscope, Rigid, 2); EOB (Nasopharyngoscope (Flexible Or Rigid), 1).
Next steps
- See all 9 Wilson Greatbatch Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Wilson Greatbatch Technologies, Inc.'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.