Innovative Surgical Products, Inc.: FDA clearances and approvals
Innovative Surgical Products, Inc. has 12 FDA 510(k) clearances (first 1980, latest 1984), across 9 product codes in 4 review panels. Median 510(k) review time: 34 days.
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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 | 2 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| FSE | Table, Operating-Room, Manual | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 1 | 1 |
| KYB | Lens, Guide, Intraocular | 1 | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 | 1 |
| LXP | Plug, Scleral | 1 | 1 |
Review panels
Most recent Innovative Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843041 | HESLIN DISPOS. TUBING SET | HQE | 1984-11-21 | 111 |
| K840695 | PHACOEMULSIFICATION KITS | HQC | 1984-05-22 | 96 |
| K840693 | DISPOSABLE SCLERAL GLOBE PLUG | LXP | 1984-05-22 | 96 |
| K840694 | LENS INSERTION GLIDE | KYB | 1984-05-09 | 83 |
| K841072 | IRRIGATION, ASPIRATION TUBING SETS | HQC | 1984-03-29 | 17 |
| K832235 | DISPOSABLE VITRECTOMY HANDPIECE | HQE | 1983-09-29 | 80 |
| K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM | KDH | 1982-06-22 | 34 |
| K820765 | PLEURAL DRAINAGE RESERVOIR | GCX | 1982-04-15 | 24 |
| K820680 | DISPOSABLE TUBING SETS | KYG | 1982-04-09 | 29 |
| K802973 | ISPVAC TM | GCY | 1980-12-19 | 31 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innovative Surgical Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Innovative Surgical Products, Inc. have?
Innovative Surgical Products, Inc. has 12 FDA 510(k) clearances (first 1980, latest 1984), across 9 product codes in 4 review panels.
How long does FDA take to clear Innovative Surgical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Innovative Surgical Products, Inc.'s cleared 510(k)s is 34 days.
What devices does Innovative Surgical Products, Inc. make?
Its most frequent FDA product codes are GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 2); HQC (Unit, Phacofragmentation, 2); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 2).
Has Innovative Surgical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Innovative Surgical Products, Inc. Related entities may recall under other names.
Next steps
- See all 12 Innovative Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCY, Innovative Surgical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.