Transenterix, Inc
FDA Regulatory Profile
Transenterix, Inc appears in FDA public data with 1 recall, 15 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2137-2012, Class II) was initiated on July 2, 2012. Its most recent 510(k) clearance was granted on March 2, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2137-2012 | Class II | SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended f | July 2, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K202166 | Senhance Surgical System | March 2, 2021 |
| K200049 | Senhance Surgical System | March 9, 2020 |
| K192877 | Senhance Surgical System | November 22, 2019 |
| K191482 | Senhance Surgical System | July 11, 2019 |
| K182421 | Senhance Ultrasonic System | January 11, 2019 |
| K183098 | Senhance Surgical System | December 6, 2018 |
| K181517 | Senhance Surgical System | October 9, 2018 |
| K180163 | TransEnterix Senhance Surgical System | May 25, 2018 |
| K171120 | Senhance Surgical Robotic System | October 13, 2017 |
| K122299 | SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, | October 25, 2012 |
| K120403 | SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER | April 16, 2012 |
| K102839 | SPIDER STANDARD AND ADVANCED | March 15, 2011 |
| K102646 | SPIDER FLEX MONOPOLAR HOOK | November 3, 2010 |
| K091697 | SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 | September 28, 2009 |
| K090902 | SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 | July 22, 2009 |