Micromedics, Inc.: FDA clearances and approvals
Micromedics, Inc. has 29 FDA 510(k) clearances (first 1983, latest 2024), across 17 product codes in 5 review panels. Median 510(k) review time: 84 days. openFDA lists 5 product recalls by a recalling firm named Micromedics, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 52 |
| 2013 | 1 | 25 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Micromedics, Inc.'s cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| FMF | Syringe, Piston | 4 | 4 |
| KYZ | Syringe, Irrigating (Non Dental) | 4 | 4 |
| ETD | Tube, Tympanostomy | 2 | 2 |
| KAM | Cannula, Sinus | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| EQJ | Bur, Ear, Nose And Throat | 1 | 1 |
| ESX | Tack, Sacculotomy (Cody Tack) | 1 | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 1 | 1 |
Plus 7 more product codes.
Review panels
- Ear, Nose and Throat (9)
- General Hospital (9)
- General and Plastic Surgery (8)
- Anesthesiology (1)
- Neurology (1)
Most recent Micromedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241739 | Endoscopic Applicator, 41 cm | GCJ | 2024-07-15 | 28 |
| K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR | GCJ | 2013-01-08 | 25 |
| K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR | GCJ | 2012-11-16 | 88 |
| K120608 | ENDOSCOPIC APPLICATOR | GCJ | 2012-03-15 | 15 |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | KYZ | 2011-03-15 | 189 |
| K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | FMF | 2010-06-09 | 84 |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | MJV | 2008-03-14 | 101 |
| K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | FMF | 2006-09-13 | 147 |
| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | KCT | 2005-09-01 | 119 |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | KAM | 2005-04-27 | 75 |
19 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-10-20.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Micromedics, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Micromedics, Inc. have?
Micromedics, Inc. has 29 FDA 510(k) clearances (first 1983, latest 2024), across 17 product codes in 5 review panels.
How long does FDA take to clear Micromedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Micromedics, Inc.'s cleared 510(k)s is 84 days.
What devices does Micromedics, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 5); FMF (Syringe, Piston, 4); KYZ (Syringe, Irrigating (Non Dental), 4).
Has Micromedics, Inc. had device recalls?
openFDA lists 5 product recalls in 2 recall events by a recalling firm whose name matches Micromedics, Inc; the most recent began 2016-10-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 29 Micromedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Micromedics, 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.