510(k) Report

FDA applicant

Transenterix, Inc.

Morrisville, NC15 decisions2009–20214 recalls

FDA records 15 decisions for Transenterix, Inc. (Morrisville, NC) from 2009 to 2021: 15 510(k) clearances. Most are in product codes NAY (System, Surgical, Computer Controlled Instrument) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 13 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Transenterix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2009: 22010: 12011: 12012: 22017: 12018: 32019: 32020: 12021: 1
2009high 3 (2018) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2012

2010: 12011: 22012: 1
2009high 2 (2011) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Transenterix, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Transenterix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NAYSystem, Surgical, Computer Controlled Instrument9decisions
  • GCJLaparoscope, General & Plastic Surgery6decisions

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 123 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 6 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091697Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015Transenterix, Inc. · 20095cite it
  • K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 20093cite it
  • K102646Spider Flex Monopolar HookTransenterix, Inc. · 20102cite it
  • K202166Senhance Surgical SystemTransenterix, Inc. · 20212cite it
  • K171120Senhance Surgical Robotic SystemTransenterix, Inc. · 20172cite it
  • K181517Senhance Surgical SystemTransenterix, Inc. · 20182cite it

What has FDA decided for it lately?

  • K202166Senhance Surgical SystemTransenterix, Inc. · 2021
  • K200049Senhance Surgical SystemTransenterix, Inc. · 2020
  • K192877Senhance Surgical SystemTransenterix, Inc. · 2019
  • K191482Senhance Surgical SystemTransenterix, Inc. · 2019
  • K182421Senhance Ultrasonic SystemTransenterix, Inc. · 2019
  • K183098Senhance Surgical SystemTransenterix, Inc. · 2018
  • K181517Senhance Surgical SystemTransenterix, Inc. · 2018
  • K180163TransEnterix Senhance Surgical SystemTransenterix, Inc. · 2018

All 15 as Transenterix, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K091697SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are…Jul 2, 2012Class II
  • K090902SPIDER Surgical Platform The SPIDER is a single port, single incision device to…Feb 25, 2011
  • K102839SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to…Feb 25, 2011
  • K091697Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NCJun 22, 2010