AquaShield system CO2, AquaShield system-PENTAX— 510(k) K153362

Name: FDA 510(k) clearance K153362
Creator: U.S. Food and Drug Administration
Published: 2015-12-16

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K153362 for AquaShield system CO2, AquaShield system-PENTAX, Substantially Equivalent on 2015-12-16. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FEQ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-11-20
Decision date: 2015-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FEQ

view all

More clearances from United States Endoscopy Group, Inc.

view all

K192265 — gi-4000 Electrosurgical Generator2020-05-21
K200745 — Lariat, Hot/Cold Snare2020-04-21
K192059 — Bio Guard Air/Water & Suction Valves2019-09-17
K182909 — Roth Net Retriever Product Line2018-11-21
K172805 — gi-4000 Electrosurgical Generator2017-10-23

Adverse events under product code FEQ

product code FEQ

Malfunction: 1,135
Total: 1,135

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.