American Surgical Instruments Corp.: FDA clearances and approvals
American Surgical Instruments Corp. has 6 FDA 510(k) clearances (first 1990, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time: 172 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent American Surgical Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921716 | DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM | HET | 1993-11-08 | 578 |
| K921457 | IRRIGATION PUMPS AND TUBING AND SUCTION TUBING | GCJ | 1993-05-13 | 413 |
| K913944 | NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES | HET | 1992-03-09 | 187 |
| K913999 | NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE | GCJ | 1991-11-01 | 56 |
| K911274 | UNIPOLAR COAGULATOR PROBE SYSTEM | GEI | 1991-06-20 | 90 |
| K896118 | NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE | HET | 1990-03-28 | 156 |
Recalls
openFDA lists no recalls under a recalling firm named American Surgical Instruments 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 American Surgical Instruments Corp. have?
American Surgical Instruments Corp. has 6 FDA 510(k) clearances (first 1990, latest 1993), across 3 product codes in 2 review panels.
How long does FDA take to clear American Surgical Instruments Corp.'s 510(k)s?
The median time from FDA receipt to decision across American Surgical Instruments Corp.'s cleared 510(k)s is 172 days.
What devices does American Surgical Instruments Corp. make?
Its most frequent FDA product codes are HET (Laparoscope, Gynecologic (And Accessories), 3); GCJ (Laparoscope, General & Plastic Surgery, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Has American Surgical Instruments Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Surgical Instruments Corp. Related entities may recall under other names.
Next steps
- See all 6 American Surgical Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code HET, American Surgical Instruments 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.