Unimed Surgical Products, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Unimed Surgical Products, Inc.” (first 1994, latest 2013), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 | 1 | 83 |
| 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 | 12 | 12 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
Review panels
Most recent Unimed Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES | GEI | 2013-10-08 | 83 |
| K993647 | UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F | GEI | 1999-11-16 | 18 |
| K970066 | UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE | GEI | 1997-02-18 | 41 |
| K963338 | UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH | GEI | 1996-10-21 | 59 |
| K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | GEI | 1996-09-03 | 36 |
| K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE | HGI | 1995-07-25 | 316 |
| K944265 | NEEDLE ELCTRODE | GEI | 1995-05-05 | 246 |
| K946246 | SURGI-LINK BIPOLAR MICRO FORCEPS | GEI | 1995-03-07 | 75 |
| K945030 | SURGI-LINK LAPAROSCOPIC ELECTRODES | GEI | 1994-11-03 | 21 |
| K944898 | SURGI-LINK BIPOLAR ELECTRODES | GEI | 1994-11-01 | 28 |
3 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2013-02-15.
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.
- Unimed Medical Supplies, Inc. (20 510(k)s)
- Unimed Hospital Supply Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unimed Surgical Products, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Unimed Surgical Products, Inc.” (first 1994, latest 2013), across 2 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 Unimed Surgical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unimed Surgical Products, Inc. is 36 days.
Which FDA product codes appear under Unimed Surgical Products, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 12); HGI (Electrocautery, Gynecologic (And Accessories), 1).
Next steps
- See all 13 Unimed Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Unimed Surgical Products, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.