Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unisurge, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
264 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943502 | UNIGRIP | Unisurge, Inc. | 1994-10-07 | 93 | 0 |
| K933720 | INSTRUMENT ACTUATING DEVICE (IAD) | Unisurge, Inc. | 1993-11-12 | 102 | 0 |
| K930605 | APPLIER, SURGICAL, CLIP | Unisurge, Inc. | 1993-10-08 | 245 | 0 |
| K930617 | OBGRIP AND UNITIPS(TM) | Unisurge, Inc. | 1993-08-11 | 184 | 0 |
| K930809 | UNITIPS | Unisurge, Inc. | 1993-08-10 | 175 | 0 |
| K925917 | UNICHANNEL(TM SURGICAL GRASPER | Unisurge, Inc. | 1993-08-10 | 260 | 0 |
| K932604 | UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC | Unisurge, Inc. | 1993-08-10 | 74 | 0 |
| K925882 | UNITIPS SURGICAL INSTRUMENTS | Unisurge, Inc. | 1993-08-10 | 264 | 0 |
| K926341 | UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT | Unisurge, Inc. | 1993-05-17 | 151 | 0 |
| K926199 | UNICLIP SURGICAL CLIP APPLIER | Unisurge, Inc. | 1993-04-20 | 132 | 0 |
| K914923 | UNISURGE DISPOSABLE TROCAR | Unisurge, Inc. | 1992-09-21 | 322 | 0 |
| K915372 | MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY | Unisurge, Inc. | 1992-04-06 | 131 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda