GASTROINTESTINAL SHEATH BRUSH— 510(k) K834402

Name: FDA 510(k) clearance K834402
Creator: U.S. Food and Drug Administration
Published: 1984-02-04

Substantially Equivalent

Hobbs Medical, Inc.

FDA 510(k) clearance K834402 for GASTROINTESTINAL SHEATH BRUSH, Substantially Equivalent on 1984-02-04. Applicant: Hobbs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hobbs Medical, Inc.
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1983-12-14
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hobbs Medical, Inc.

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K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U2010-08-02
K030765 — HOBBS MISTIFIER SPRAY CATHETER2003-06-09
K933354 — HOBBS MEDICAL CLEANING BRUSH1993-10-28

Recalls naming K834402

K-number listed on FDA's recall record

Z-2052-2018 — Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.Class II·Terminated·Hobbs Medical, Inc.·20180501

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K834402.

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