Minimally Invasive Surgical Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Minimally Invasive Surgical Technologies, Inc.” (first 1993, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time under this name: 110 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 | 6 | 6 |
Review panels
Most recent Minimally Invasive Surgical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951398 | MIST REDUCER SLEEVES | GCJ | 1995-05-03 | 36 |
| K931273 | MIST FORCEPS/CLAMPS FOR LAPAROSCOPOIC/ENDOSCOPIC | GCJ | 1993-08-11 | 156 |
| K931275 | MIST MICROSURGICAL MONOPOLAR FORCEPS | GCJ | 1993-08-05 | 150 |
| K931274 | MIST MICROSURGICAL MONOPOLAR SCISSORS | GCJ | 1993-08-05 | 150 |
| K931272 | MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDUR | GCJ | 1993-05-17 | 70 |
| K931276 | MIST RATCHETED FORCEPS FOR LAPAROSCOPIC/ENDOSCOPIC | GCJ | 1993-05-13 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Minimally Invasive Surgical Technologies, 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.
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.
- Minimally Invasive Devices, LLC (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Minimally Invasive Surgical Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Minimally Invasive Surgical Technologies, Inc.” (first 1993, latest 1995), 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 Minimally Invasive Surgical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Minimally Invasive Surgical Technologies, Inc. is 110 days.
Which FDA product codes appear under Minimally Invasive Surgical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6).
Next steps
- See all 6 Minimally Invasive Surgical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Minimally Invasive Surgical Technologies, 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.