Surgeons Choice, Inc.: FDA clearances and approvals
Surgeons Choice, Inc. has 6 FDA 510(k) clearances (first 1982, latest 1985), across 3 product codes in 1 review panel. Median 510(k) review time: 37 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 |
|---|---|---|---|
| GAG | Stapler, Surgical | 3 | 3 |
| GDW | Staple, Implantable | 2 | 2 |
| FZQ | Clip, Removable (Skin) | 1 | 1 |
Review panels
Most recent Surgeons Choice, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851122 | PI-PNEUMO INTESTINAL STAPLING CARTRIDGE | GDW | 1985-04-25 | 37 |
| K851121 | PI-PHEUMO INTESTINAL INSTRUMENT SET | GAG | 1985-04-25 | 37 |
| K843399 | SURGEONS CHOICE PI VASCULAR STAPLING | GDW | 1984-11-05 | 67 |
| K830768 | DISPOSABLE SKIN STAPLER | FZQ | 1983-04-12 | 32 |
| K823776 | PI-PNEUMO-INTESTINAL INSTRUMENT SET | GAG | 1983-01-14 | 30 |
| K813170 | ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER | GAG | 1982-02-12 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Surgeons Choice, 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 Surgeons Choice, Inc. have?
Surgeons Choice, Inc. has 6 FDA 510(k) clearances (first 1982, latest 1985), across 3 product codes in 1 review panel.
How long does FDA take to clear Surgeons Choice, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Surgeons Choice, Inc.'s cleared 510(k)s is 37 days.
What devices does Surgeons Choice, Inc. make?
Its most frequent FDA product codes are GAG (Stapler, Surgical, 3); GDW (Staple, Implantable, 2); FZQ (Clip, Removable (Skin), 1).
Has Surgeons Choice, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgeons Choice, Inc. Related entities may recall under other names.
Next steps
- See all 6 Surgeons Choice, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAG, Surgeons Choice, 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.