Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transenterix, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
182 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202166 | Senhance Surgical System | Transenterix, Inc. | 2021-03-02 | 211 | 0 |
| K200049 | Senhance Surgical System | Transenterix, Inc. | 2020-03-09 | 60 | 0 |
| K192877 | Senhance Surgical System | Transenterix, Inc. | 2019-11-22 | 45 | 0 |
| K191482 | Senhance Surgical System | Transenterix, Inc. | 2019-07-11 | 37 | 0 |
| K182421 | Senhance Ultrasonic System | Transenterix, Inc. | 2019-01-11 | 128 | 0 |
| K183098 | Senhance Surgical System | Transenterix, Inc. | 2018-12-06 | 29 | 0 |
| K181517 | Senhance Surgical System | Transenterix, Inc. | 2018-10-09 | 123 | 0 |
| K180163 | TransEnterix Senhance Surgical System | Transenterix, Inc. | 2018-05-25 | 126 | 0 |
| K171120 | Senhance Surgical Robotic System | Transenterix, Inc. | 2017-10-13 | 182 | 0 |
| K122299 | SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY | Transenterix, Inc. | 2012-10-25 | 86 | 0 |
| K120403 | SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER | Transenterix, Inc. | 2012-04-16 | 67 | 0 |
| K102839 | SPIDER STANDARD AND ADVANCED | Transenterix, Inc. | 2011-03-15 | 167 | 1 |
| K102646 | SPIDER FLEX MONOPOLAR HOOK | Transenterix, Inc. | 2010-11-03 | 50 | 0 |
| K091697 | SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 900 | Transenterix, Inc. | 2009-09-28 | 110 | 2 |
| K090902 | SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, M | Transenterix, Inc. | 2009-07-22 | 112 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda