United Surgical Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “United Surgical Corp.” (first 1983, latest 1990), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 46 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 | 3 | 3 |
| GAG | Stapler, Surgical | 1 | 1 |
| HPS | Unit, Cryophthalmic | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 | 1 |
Review panels
Most recent United Surgical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902150 | PIEZO HANDPIECE | HQC | 1990-07-05 | 51 |
| K870671 | PHACOTRON DAY PAK | HQC | 1987-04-06 | 46 |
| K870806 | NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 | HQC | 1987-03-26 | 28 |
| K870195 | UNITED SURGICAL CORP. CRYOPTIC PLUS | HPS | 1987-02-20 | 31 |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | HQR | 1987-02-20 | 31 |
| K860014 | SYSTEMS PLUS | HQE | 1986-03-05 | 61 |
| K830741 | PARAMETRIC STERILITY RELEASE OF AUTO | GAG | 1983-08-11 | 156 |
Recalls
openFDA lists no recalls under a recalling firm named United Surgical Corp..
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.
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Biotech, Inc. (22 510(k)s)
- United Consortium (15 510(k)s)
- United Diagnostics, Inc. (12 510(k)s)
- United Medical Industries Co. , Ltd. (10 510(k)s)
- United Pacific Co., Ltd. (6 510(k)s)
- United Dental Mfg., Inc. (5 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Sonics, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United Surgical Corp.?
FDA lists 7 510(k) clearances under the applicant name “United Surgical Corp.” (first 1983, latest 1990), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by United Surgical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name United Surgical Corp. is 46 days.
Which FDA product codes appear under United Surgical Corp.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 3); GAG (Stapler, Surgical, 1); HPS (Unit, Cryophthalmic, 1).
Next steps
- See all 7 United Surgical Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQC, United Surgical Corp.'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.