Micro-Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Micro-Medical Devices, Inc.” (first 1994, latest 2001), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 132 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 | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| HXR | Spatula, Orthopedic | 1 | 1 |
Review panels
Most recent Micro-Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003695 | MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES | HRX | 2001-02-14 | 76 |
| K983882 | MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 | HXR | 1999-03-15 | 133 |
| K963675 | THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE | KKX | 1997-01-27 | 136 |
| K951482 | ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) | GCJ | 1995-09-14 | 168 |
| K951894 | ACCESS EXPANSION SYSTEM | FHO | 1995-06-15 | 52 |
| K945656 | THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE | KKX | 1995-03-28 | 131 |
| K940141 | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | GCJ | 1994-05-19 | 128 |
| K936213 | ARTHROSCOPES AND ACCESSORIES | HRX | 1994-05-18 | 140 |
Recalls
openFDA lists no recalls under a recalling firm named Micro-Medical Devices, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro-Medical Devices, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Micro-Medical Devices, Inc.” (first 1994, latest 2001), across 5 product codes in 4 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-Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro-Medical Devices, Inc. is 132 days.
Which FDA product codes appear under Micro-Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); HRX (Arthroscope, 2); KKX (Drape, Surgical, Antimicrobial, 2).
Next steps
- See all 8 Micro-Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Micro-Medical Devices, 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.