Microquartz Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Microquartz Medical, Inc.” (first 1995, latest 1996), across 1 product code in 1 review panel. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
Review panels
Most recent Microquartz Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955861 | MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER | GEX | 1996-01-26 | 30 |
| K954904 | MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER | GEX | 1996-01-22 | 89 |
| K953065 | ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) | GEX | 1995-09-27 | 89 |
| K953174 | MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY | GEX | 1995-08-28 | 52 |
| K952974 | QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER) | GEX | 1995-08-28 | 62 |
| K950710 | MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER | GEX | 1995-03-10 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Microquartz Medical, 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 Microquartz Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Microquartz Medical, Inc.” (first 1995, latest 1996), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microquartz Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microquartz Medical, Inc. is 57 days.
Which FDA product codes appear under Microquartz Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6).
Next steps
- See all 6 Microquartz Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Microquartz Medical, 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.