General Surgical Innovations: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “General Surgical Innovations” (first 1993, latest 1999), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 134 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 | 10 | 10 |
| DYB | Introducer, Catheter | 1 | 1 |
| FZW | Expander, Surgical, Skin Graft | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| MRD | Mammary Sizer | 1 | 1 |
Review panels
Most recent General Surgical Innovations 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983318 | FIXATION SYSTEM | GDW | 1999-03-01 | 161 |
| K973046 | SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK | GCJ | 1998-01-16 | 154 |
| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | FZW | 1997-11-14 | 162 |
| K970201 | GSI CANNULA WITH INTRODUCER | DYB | 1997-04-21 | 90 |
| K962702 | SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA | GCJ | 1997-02-19 | 222 |
| K961356 | MAMMARY SIZER | MRD | 1996-09-23 | 168 |
| K952278 | THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA | GCJ | 1995-08-07 | 84 |
| K951878 | SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA | GCJ | 1995-06-29 | 84 |
| K944418 | THE SPACEMAKER AND THE SPACEMAKER II | GCJ | 1994-11-01 | 54 |
| K944536 | GSI KNOTMAKER | GCJ | 1994-10-05 | 20 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named General Surgical Innovations.
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.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Surgical Innovations?
FDA lists 14 510(k) clearances under the applicant name “General Surgical Innovations” (first 1993, latest 1999), across 5 product codes in 2 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 General Surgical Innovations?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Surgical Innovations is 134 days.
Which FDA product codes appear under General Surgical Innovations?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 10); DYB (Introducer, Catheter, 1); FZW (Expander, Surgical, Skin Graft, 1).
Next steps
- See all 14 General Surgical Innovations clearances with predicates and recalls
- Run predicate analysis for product code GCJ, General Surgical Innovations'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.