Microvasive: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Microvasive” (first 1983, latest 1987), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 5 | 5 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 3 |
| BYZ | Trap, Sterile Specimen | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GCM | Endoscope, Rigid | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Microvasive 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872771 | LOW PROFILE GASTROSTOMY | KNT | 1987-10-09 | 87 |
| K870705 | THERMAL COAGULATOR | KNS | 1987-04-17 | 56 |
| K861323 | REPLACEMENT GASTROSTOMY TUBE | KNT | 1986-12-16 | 252 |
| K861309 | JEJUNAL FEEDING TUBE | KNT | 1986-12-16 | 252 |
| K860589 | INFLATOR/DEFLATOR PISTON SYRINGE | KNT | 1986-04-07 | 47 |
| K860366 | CHALLENGER HOT BIOPSY FORCEPS | KNS | 1986-04-07 | 63 |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | GAA | 1985-11-13 | 23 |
| K854063 | MICROVASIVE SILICONE SPRAY | KCT | 1985-10-25 | 21 |
| K851652 | PAPILLOTOME | KNS | 1985-06-24 | 63 |
| K850393 | FLEXIBLE FIBEROPTIC ENDOSCOPE | — | 1985-06-04 | 123 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microvasive.
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 Microvasive?
FDA lists 18 510(k) clearances under the applicant name “Microvasive” (first 1983, latest 1987), across 12 product codes in 3 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 Microvasive?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microvasive is 58 days.
Which FDA product codes appear under Microvasive?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 5); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 3); BYZ (Trap, Sterile Specimen, 1).
Next steps
- See all 18 Microvasive clearances with predicates and recalls
- Run predicate analysis for product code KNT, Microvasive'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.