Company ยท US
Transenterix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2021. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 2021 | K202166 | Senhance Surgical System Transenterix, Inc. | NAY |
| Mar 9, 2020 | K200049 | Senhance Surgical System Transenterix, Inc. | NAY |
| Nov 22, 2019 | K192877 | Senhance Surgical System Transenterix, Inc. | NAY |
| Jul 11, 2019 | K191482 | Senhance Surgical System Transenterix, Inc. | NAY |
| Jan 11, 2019 | K182421 | Senhance Ultrasonic System Transenterix, Inc. | NAY |
| Dec 6, 2018 | K183098 | Senhance Surgical System Transenterix, Inc. | NAY |
| Oct 9, 2018 | K181517 | Senhance Surgical System Transenterix, Inc. | NAY |
| May 25, 2018 | K180163 | TransEnterix Senhance Surgical System Transenterix, Inc. | NAY |
| Oct 13, 2017 | K171120 | Senhance Surgical Robotic System Transenterix, Inc. | NAY |
| Oct 25, 2012 | K122299 | SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR Transenterix, Inc. | GCJ |
| Apr 16, 2012 | K120403 | SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER Transenterix, Inc. | GCJ |
| Mar 15, 2011 | K102839 | SPIDER STANDARD AND ADVANCED Transenterix, Inc. | GCJ |
| Nov 3, 2010 | K102646 | SPIDER FLEX MONOPOLAR HOOK Transenterix, Inc. | GCJ |
| Sep 28, 2009 | K091697 | SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 Transenterix, Inc. | GCJ |
| Jul 22, 2009 | K090902 | SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 Transenterix, Inc. | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2012 | Transenterix, Inc SPIDER Surgical Instrument: Flexible Clip Applier
The SPIDER Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutt Terminated |
GCJ | K091697 |
| Apr 8, 2011 | Transenterix, Inc SPIDER ADVANCED Surgical Platform
The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-s Terminated |
GCJ | K102839 |
| Apr 8, 2011 | Transenterix, Inc SPIDER Surgical Platform
The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-steriliz Terminated |
GCJ | K090902 |
| Sep 22, 2010 | Transenterix, INC Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC Terminated |
GCJ | K091697 |