510(k) Report

FDA applicant

United States Endoscopy Group, Inc.

Mentor, OH94 decisions1991–20209 recalls

FDA records 94 decisions for United States Endoscopy Group, Inc. (Mentor, OH) from 1991 to 2020: 94 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FDI (Snare, Flexible). Since 2016 its 510(k)s took a median of 41 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 5 of them its own earlier devices. 9 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 United States Endoscopy Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2007: 12009: 22010: 42011: 42012: 42013: 22014: 42015: 52017: 32018: 32019: 22020: 2
2007high 5 (2015) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2022

2011: 22013: 12014: 12015: 22016: 22022: 1
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like United States Endoscopy Group, 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 Surgery11decisions
  • FDISnare, Flexible10decisions
  • KNTTubes, Gastrointestinal (And Accessories)6decisions
  • FEQPump, Air, Non-Manual, For Endoscope6decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions
  • OCXEndoscopic Irrigation/Suction System4decisions

Also: FCK (4), FDX (4), FED (4), KNS (3), ODC (3), KGE (2).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 41 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 78 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 55 times; 5 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.

  • K040836Disposable OvertubeUnited States Endoscopy Group, Inc. · 200410cite it
  • K070420Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 20074cite it
  • K971842Coaxial NeedleUnited States Endoscopy Group, Inc. · 19972cite it
  • K040961Injector Needle/SnareUnited States Endoscopy Group, Inc. · 20042cite it
  • K103239Irrigation SystemUnited States Endoscopy Group, Inc. · 20102cite it
  • K101146Water Bottle Cap SystemUnited States Endoscopy Group, Inc. · 20102cite it

What has FDA decided for it lately?

  • K192265gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc. · 20201 recall
  • K200745Lariat, Hot/Cold SnareUnited States Endoscopy Group, Inc. · 2020
  • K192059Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc. · 2019
  • K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc. · 2019
  • K182909Roth Net Retriever Product LineUnited States Endoscopy Group, Inc. · 2018
  • K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc. · 2018
  • K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc. · 2018
  • K172805gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc. · 2017

All 94 as United States Endoscopy Group, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K192265GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform…Oct 17, 2022Class II
  • K122462Roth Net Polyp RetrievalDec 13, 2016Class III
  • K971842Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile…May 18, 2016Class II
  • K962676Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies…Mar 10, 2015Class II
  • K092461Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy…Feb 17, 2015Class II
  • K070420UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a…Oct 31, 2014Class II