MULTIPLE BIOPSY SYSTEM— 510(k) K103326

Name: FDA 510(k) clearance K103326
Creator: U.S. Food and Drug Administration
Published: 2011-04-06

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K103326 for MULTIPLE BIOPSY SYSTEM, Substantially Equivalent on 2011-04-06. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FCK
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2010-11-12
Decision date: 2011-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCK

view all

K153763 — Howell Biliary Aspiration Needle2017-04-06
K062159 — RB12 SUCTION RECTAL BIOPSY SYSTEM2006-09-05
K061201 — DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 007110872006-05-30
K051637 — DSNARE, MODEL 007110872005-10-31
K954693 — MEHTA BRONCHIAL BIOSPY DRILL1995-10-23

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
K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM2019-08-01
K182909 — Roth Net Retriever Product Line2018-11-21

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