Micro Surgical Instruments Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Micro Surgical Instruments Corp.” (first 1989, latest 1994), across 10 product codes in 6 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | 3 | 3 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 3 | 3 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| HXJ | Staple Driver | 1 | 1 |
| IME | Pack, Hot Or Cold, Reusable | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| KFK | Saw, Pneumatically Powered | 1 | 1 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 1 | 1 |
Review panels
- Orthopedic (7)
- General and Plastic Surgery (4)
- Dental (1)
- Ear, Nose and Throat (1)
- Neurology (1)
- Physical Medicine (1)
Most recent Micro Surgical Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | KIJ | 1994-01-28 | 315 |
| K932492 | IMPLANTOLOGY MODULE, MODEL 2175 | JEY | 1993-10-05 | 134 |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | HXJ | 1993-08-02 | 199 |
| K914998 | MICROAIRE(R) FACIAL BONE PLATING SYSTEM | HRS | 1992-06-02 | 208 |
| K915139 | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE | HSZ | 1992-02-05 | 84 |
| K914346 | DRILL MODULES MODELS 2116/2117 | ERL | 1991-11-27 | 61 |
| K913369 | MICRO-AIRE MODEL 2060 | GEY | 1991-11-01 | 95 |
| K913266 | MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS | GEY | 1991-10-21 | 90 |
| K910175 | FIXATION DEVICES AND BONE PLATE | HRS | 1991-06-21 | 157 |
| K905383 | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY | GEY | 1991-06-18 | 201 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Micro Surgical Instruments Corp..
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.
- Micro Media Laboratories (52 510(k)s)
- Micro Therapeutics, Inc. (51 510(k)s)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (32 510(k)s)
- Micro Motors, Inc. (14 510(k)s)
- Micro Detect, Inc. (11 510(k)s)
- Micro Direct, Inc. (9 510(k)s)
- Micro Current Technology, Inc. (8 510(k)s)
- Micro Audiometrics Corp. (6 510(k)s)
- Micro Tronics Corp. (6 510(k)s)
- Micro Specialties, Inc. (4 510(k)s)
- Micro Dental Laboratories (3 510(k)s)
- Micro Encapsulation Tech. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro Surgical Instruments Corp.?
FDA lists 15 510(k) clearances under the applicant name “Micro Surgical Instruments Corp.” (first 1989, latest 1994), across 10 product codes in 6 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 Micro Surgical Instruments Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro Surgical Instruments Corp. is 90 days.
Which FDA product codes appear under Micro Surgical Instruments Corp.?
The most frequent FDA product codes under this applicant name are GEY (Motor, Surgical Instrument, Ac-Powered, 3); HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, 3); HRS (Plate, Fixation, Bone, 2).
Next steps
- See all 15 Micro Surgical Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEY, Micro Surgical Instruments Corp.'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.