American Surgical Co., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “American Surgical Co., Inc.” (first 1983, latest 1986), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 5 | 5 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 4 | 4 |
Review panels
- Ophthalmic (9)
Most recent American Surgical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834162 | VIT PAC | HQE | 1986-02-07 | 847 |
| K834160 | VITREONIC PLUS | HQE | 1986-02-07 | 847 |
| K841738 | AMER. SURGICAL CORP. EXTRA PLUS PAK | HQE | 1984-10-05 | 161 |
| K834163 | ULTRAVIT | HQE | 1983-12-28 | 75 |
| K834161 | UNIVERSAL PAC | HQC | 1983-12-28 | 75 |
| K834159 | PHACOTRON PLUS | HQC | 1983-12-28 | 75 |
| K834158 | EXTRA SENSORY PLUS | HQC | 1983-12-28 | 75 |
| K833697 | EXTRA SENSORY PAK-DISPOS. ACCESS | HQC | 1983-12-28 | 71 |
| K833617 | EXTRA PLUS TM | HQC | 1983-12-28 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named American Surgical Co., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Surgical Co., Inc.?
FDA lists 9 510(k) clearances under the applicant name “American Surgical Co., Inc.” (first 1983, latest 1986), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Surgical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Surgical Co., Inc. is 75 days.
Which FDA product codes appear under American Surgical Co., Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 5); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 4).
Next steps
- See all 9 American Surgical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, American Surgical Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.