Surgical Products Corp.: FDA clearances and approvals
Surgical Products Corp. has 6 FDA 510(k) clearances (first 1984, latest 1992), across 5 product codes in 2 review panels. Median 510(k) review time: 70 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| FZT | Cutter, Surgical | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Surgical Products Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921671 | SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE | GEX | 1992-06-18 | 71 |
| K861614 | GHI WET PENCIL | GEI | 1986-07-08 | 70 |
| K841241 | ANTERIOR CRUCIATE LIGAMENT GRASPER | HRX | 1985-02-06 | 320 |
| K841328 | SPC ARTHROSCOPY TABLE | — | 1984-05-02 | 50 |
| K841247 | SPC DISPOSABLE CUTTER | FZT | 1984-05-02 | 42 |
| K834434 | MACH I ELECTROSURGERY HAND CONTROL | GEI | 1984-04-25 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Surgical Products Corp..
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 Surgical Products Corp. have?
Surgical Products Corp. has 6 FDA 510(k) clearances (first 1984, latest 1992), across 5 product codes in 2 review panels.
How long does FDA take to clear Surgical Products Corp.'s 510(k)s?
The median time from FDA receipt to decision across Surgical Products Corp.'s cleared 510(k)s is 70 days.
What devices does Surgical Products Corp. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); FZT (Cutter, Surgical, 1); GEX (Powered Laser Surgical Instrument, 1).
Has Surgical Products Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgical Products Corp. Related entities may recall under other names.
Next steps
- See all 6 Surgical Products Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Surgical Products Corp.'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.