Unisurge, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Unisurge, Inc.” (first 1992, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 163 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 10 | 10 |
| GDO | Applier, Surgical, Clip | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Review panels
Most recent Unisurge, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943502 | UNIGRIP | GCJ | 1994-10-07 | 93 |
| K933720 | INSTRUMENT ACTUATING DEVICE (IAD) | GCJ | 1993-11-12 | 102 |
| K930605 | APPLIER, SURGICAL, CLIP | GCJ | 1993-10-08 | 245 |
| K930617 | OBGRIP AND UNITIPS(TM) | GCJ | 1993-08-11 | 184 |
| K932604 | UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC | GCJ | 1993-08-10 | 74 |
| K930809 | UNITIPS | GCJ | 1993-08-10 | 175 |
| K925917 | UNICHANNEL(TM SURGICAL GRASPER | GCJ | 1993-08-10 | 260 |
| K925882 | UNITIPS SURGICAL INSTRUMENTS | GCJ | 1993-08-10 | 264 |
| K926341 | UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT | GCJ | 1993-05-17 | 151 |
| K926199 | UNICLIP SURGICAL CLIP APPLIER | GDO | 1993-04-20 | 132 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Unisurge, 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.
- Unisurge Holding, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unisurge, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Unisurge, Inc.” (first 1992, latest 1994), across 3 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 Unisurge, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unisurge, Inc. is 163 days.
Which FDA product codes appear under Unisurge, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 10); GDO (Applier, Surgical, Clip, 1); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 12 Unisurge, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Unisurge, 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.