Transenterix, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Transenterix, Inc.” (first 2009, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 110 days. Since 2017 the median was 123 days, against 99 days for all cleared 510(k)s in the same product codes. 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 | 2 | 76 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 182 |
| 2018 | 3 | 123 |
| 2019 | 3 | 45 |
| 2020 | 1 | 60 |
| 2021 | 1 | 211 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Transenterix, Inc. took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | 9 | 9 |
| GCJ | Laparoscope, General & Plastic Surgery | 6 | 6 |
Review panels
Most recent Transenterix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202166 | Senhance Surgical System | NAY | 2021-03-02 | 211 |
| K200049 | Senhance Surgical System | NAY | 2020-03-09 | 60 |
| K192877 | Senhance Surgical System | NAY | 2019-11-22 | 45 |
| K191482 | Senhance Surgical System | NAY | 2019-07-11 | 37 |
| K182421 | Senhance Ultrasonic System | NAY | 2019-01-11 | 128 |
| K183098 | Senhance Surgical System | NAY | 2018-12-06 | 29 |
| K181517 | Senhance Surgical System | NAY | 2018-10-09 | 123 |
| K180163 | TransEnterix Senhance Surgical System | NAY | 2018-05-25 | 126 |
| K171120 | Senhance Surgical Robotic System | NAY | 2017-10-13 | 182 |
| K122299 | SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR | GCJ | 2012-10-25 | 86 |
5 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2012-07-02.
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 Transenterix, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Transenterix, Inc.” (first 2009, latest 2021), across 2 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 Transenterix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Transenterix, Inc. is 110 days. Since 2017: 123 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Transenterix, Inc.?
The most frequent FDA product codes under this applicant name are NAY (System, Surgical, Computer Controlled Instrument, 9); GCJ (Laparoscope, General & Plastic Surgery, 6).
Next steps
- See all 15 Transenterix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAY, Transenterix, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.