Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microsurge, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
233 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964109 | MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE | Microsurge, Inc. | 1996-11-27 | 43 | 0 |
| K960554 | DETACHATIP THORACOSCOPIC SCISSORS | Microsurge, Inc. | 1996-03-05 | 25 | 0 |
| K955408 | MICROSURGE THORACOSCOPIC INSTRUMENTS | Microsurge, Inc. | 1996-01-31 | 65 | 0 |
| K954641 | ENDO-LEADER | Microsurge, Inc. | 1995-12-28 | 79 | 0 |
| K954072 | MICROSURGE PUNCTURE CLOSE DEVICE | Microsurge, Inc. | 1995-10-26 | 57 | 0 |
| K954520 | MICROSURGE VERESS NEEDLE | Microsurge, Inc. | 1995-10-16 | 18 | 0 |
| K953121 | MICROSURGE THORACOSCOPIC ACCESS SYSTEM | Microsurge, Inc. | 1995-09-29 | 86 | 0 |
| K951230 | MICROSURGE BIPOLAR GRASPERS | Microsurge, Inc. | 1995-06-14 | 86 | 0 |
| K933750 | MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF | Microsurge, Inc. | 1994-06-10 | 330 | 0 |
| K930355 | MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS | Microsurge, Inc. | 1993-06-08 | 134 | 0 |
| K925830 | MICROSURGE SUCTION/IRRIGATION SYSTEM | Microsurge, Inc. | 1993-05-17 | 181 | 0 |
| K924283 | MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS | Microsurge, Inc. | 1993-04-07 | 225 | 12 |
| K922802 | MICROSURGE FRONT-END GRASPING DEVICES | Microsurge, Inc. | 1993-01-29 | 233 | 0 |
| K914175 | MICROSURGE LASER FIBER WITH SMA CONNECTOR | Microsurge, Inc. | 1991-12-17 | 90 | 0 |
| K912332 | MICROSURGE LASER FIBER HOLDER | Microsurge, Inc. | 1991-08-21 | 89 | 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