510(k) Report

FDA applicant

Surgiquest, Inc.

Orange, CT9 decisions2007–201511 recalls

FDA records 9 decisions for Surgiquest, Inc. (Orange, CT) from 2007 to 2015: 9 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HIF (Insufflator, Laparoscopic). Its devices cite 26 predicates, 10 of them its own earlier devices. 11 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 Surgiquest, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 22008: 12009: 12010: 12011: 12012: 12013: 12015: 1
2007high 2 (2007) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

11in 2026

2026 (partial year): 11
2007high 11 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Surgiquest, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery6decisions
  • HIFInsufflator, Laparoscopic3decisions

Whose devices does it build on?

Its devices cite 26 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 10 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.

  • K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 20115cite it
  • K063859Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 20073cite it
  • K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 20122cite it
  • K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 20082cite it
  • K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 20152cite it
  • K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 20071cites it

What has FDA decided for it lately?

  • K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 201511 recalls
  • K132169Surgiquest Airseal IfsSurgiquest, Inc. · 2013
  • K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2012
  • K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011
  • K100180Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010
  • K092504Surgiquest Airseal Optical Trocar and Cannula SystemSurgiquest, Inc. · 2009
  • K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008
  • K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007

All 9 as Surgiquest, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K143404ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip…May 14, 2026Class II
  • K143404ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip…May 14, 2026Class II
  • K143404ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip…May 14, 2026Class II
  • K143404ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog…May 14, 2026Class II
  • K143404ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip…May 14, 2026Class II
  • K143404ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip…May 14, 2026Class II