Microsurge, Inc.: FDA clearances and approvals
Microsurge, Inc. has 15 FDA 510(k) clearances (first 1991, latest 1996), across 6 product codes in 3 review panels. Median 510(k) review time: 86 days.
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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| FZP | Clip, Implantable | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| OCW | Endoscopic Tissue Approximation Device | 1 | 1 |
Review panels
Most recent Microsurge, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964109 | MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP | FZP | 1996-11-27 | 43 |
| K960554 | DETACHATIP THORACOSCOPIC SCISSORS | GEI | 1996-03-05 | 25 |
| K955408 | MICROSURGE THORACOSCOPIC INSTRUMENTS | GCJ | 1996-01-31 | 65 |
| K954641 | ENDO-LEADER | OCW | 1995-12-28 | 79 |
| K954072 | MICROSURGE PUNCTURE CLOSE DEVICE | GCJ | 1995-10-26 | 57 |
| K954520 | MICROSURGE VERESS NEEDLE | HET | 1995-10-16 | 18 |
| K953121 | MICROSURGE THORACOSCOPIC ACCESS SYSTEM | GCJ | 1995-09-29 | 86 |
| K951230 | MICROSURGE BIPOLAR GRASPERS | GEI | 1995-06-14 | 86 |
| K933750 | MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF | GCJ | 1994-06-10 | 330 |
| K930355 | MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS | GEI | 1993-06-08 | 134 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microsurge, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Microsurge, Inc. have?
Microsurge, Inc. has 15 FDA 510(k) clearances (first 1991, latest 1996), across 6 product codes in 3 review panels.
How long does FDA take to clear Microsurge, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Microsurge, Inc.'s cleared 510(k)s is 86 days.
What devices does Microsurge, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); GCJ (Laparoscope, General & Plastic Surgery, 4); GEX (Powered Laser Surgical Instrument, 2).
Has Microsurge, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Microsurge, Inc. Related entities may recall under other names.
Next steps
- See all 15 Microsurge, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Microsurge, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.