Microsurgical Technology, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Microsurgical Technology, Inc.” (first 1984, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | 6 | 6 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| LCC | Applicator, Ocular Pressure | 1 | 1 |
Review panels
- Ophthalmic (9)
Most recent Microsurgical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953959 | PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES | HQC | 1995-11-17 | 87 |
| K946194 | WEE BAG O'MERCURY | LCC | 1995-02-27 | 69 |
| K943672 | PHACO NEEDLES AND TIPS | HQC | 1994-10-13 | 79 |
| K942403 | INFUSION CANNULA | HMX | 1994-08-17 | 90 |
| K934844 | INTER TIP T | HMX | 1994-04-19 | 193 |
| K854402 | THE NEW MCINTYRE I.A. HANDPIECE | HMX | 1985-12-30 | 60 |
| K854401 | THE NEW MOBILE TIP MCINTYRE CANNULA | HMX | 1985-12-30 | 60 |
| K853777 | THE NEW MCINTYRE CANNULA | HMX | 1985-11-21 | 73 |
| K840442 | STERILIZED DISPOS. CYSTOTOME | HMX | 1984-03-16 | 44 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-08-20.
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.
- Microsurgical Laboratories,Inc.Dba Wexler Surgical (3 510(k)s)
- Microsurgical Systems, Inc. (2 510(k)s)
- Microsurgical Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microsurgical Technology, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Microsurgical Technology, Inc.” (first 1984, latest 1995), across 3 product codes 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 Microsurgical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microsurgical Technology, Inc. is 73 days.
Which FDA product codes appear under Microsurgical Technology, Inc.?
The most frequent FDA product codes under this applicant name are HMX (Cannula, Ophthalmic, 6); HQC (Unit, Phacofragmentation, 2); LCC (Applicator, Ocular Pressure, 1).
Next steps
- See all 9 Microsurgical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HMX, Microsurgical Technology, 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.