Innovative Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Innovative Surgical, Inc.” (first 1993, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 146 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 | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GFI | Osteotome, Manual | 1 | 1 |
Review panels
Most recent Innovative Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945394 | INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER | GCJ | 1995-01-27 | 85 |
| K932696 | ISI(R) CURVED, TAPERED DISSECTING FORCEPS | GCJ | 1994-03-03 | 273 |
| K932695 | ISI(R) PORPOISE NOSE DISSECTING FORCEPS | GCJ | 1994-03-03 | 273 |
| K934075 | ISI METZENBAUM SCISSORS | GEI | 1993-12-01 | 103 |
| K932697 | ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR | GCJ | 1993-11-10 | 160 |
| K932698 | ISI(R) HOOK SUTURES SCISSORS | GCJ | 1993-10-27 | 146 |
| K932534 | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | GFI | 1993-08-19 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Innovative Surgical, 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.
- Innovative Health, LLC (50 510(k)s)
- Innovative Medical Systems, Inc. (22 510(k)s)
- Innovative Technologies , Ltd. (14 510(k)s)
- Innovative Surgical Products, Inc. (12 510(k)s)
- Innovative Diagnostic Systems, Inc. (11 510(k)s)
- Innovative Gloves Co;, Ltd. (9 510(k)s)
- Innovative Surgical Designs, Inc. (9 510(k)s)
- Innovative Bioceramix, Inc. (8 510(k)s)
- Innovative Medical Technologies, Inc. (6 510(k)s)
- Innovative Spinal Technologies, Inc. (4 510(k)s)
- Innovative Therapies, Inc. (4 510(k)s)
- Innovative Trauma Care, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovative Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Innovative Surgical, Inc.” (first 1993, latest 1995), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innovative Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovative Surgical, Inc. is 146 days.
Which FDA product codes appear under Innovative Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); GFI (Osteotome, Manual, 1).
Next steps
- See all 7 Innovative Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Innovative Surgical, 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.