Boston Surgical Products, Inc.: FDA clearances and approvals
Boston Surgical Products, Inc. has 17 FDA 510(k) clearances (first 1994, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time: 78 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 | 14 | 14 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 | 1 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 | 1 |
Review panels
Most recent Boston Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972311 | MODEL 20 BIPOLAR COAGULATOR | GEI | 1997-09-18 | 90 |
| K972350 | MODEL 50 BIPOLAR COAGULATOR | GEI | 1997-08-21 | 58 |
| K944947 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS | GEI | 1995-07-28 | 294 |
| K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | GFA | 1995-07-12 | 14 |
| K950375 | DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR | GEI | 1995-06-14 | 134 |
| K951912 | DISOPOSABLE & RESUABLE MONPOLAR CORD | GEI | 1995-05-12 | 18 |
| K951269 | DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL | GEI | 1995-04-24 | 34 |
| K950877 | REUSABLE MONOPOLAR FORCEPS | GEI | 1995-03-09 | 10 |
| K945171 | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE | KYG | 1995-02-08 | 110 |
| K945893 | DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE | GEI | 1994-12-13 | 11 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Boston 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 Boston Surgical Products, Inc. have?
Boston Surgical Products, Inc. has 17 FDA 510(k) clearances (first 1994, latest 1997), across 4 product codes in 2 review panels.
How long does FDA take to clear Boston Surgical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Boston Surgical Products, Inc.'s cleared 510(k)s is 78 days.
What devices does Boston Surgical Products, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 14); GFA (Blade, Saw, General & Plastic Surgery, Surgical, 1); HQO (Unit, Cautery, Thermal, Ac-Powered, 1).
Has Boston Surgical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Boston Surgical Products, Inc. Related entities may recall under other names.
Next steps
- See all 17 Boston Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Boston 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.