Cleared Traditional

K944252 - BIOPSY DEVICE ACCESSORY

K944252 is an FDA 510(k) clearance for BIOPSY DEVICE ACCESSORY, manufactured by Biopsys Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCK cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K944252 · Biopsys Medical, Inc. · Gastroenterology & Urology device
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Dec 1994
Decision
97d
Days
Class 2
Risk

K944252 is an FDA 510(k) clearance for the BIOPSY DEVICE ACCESSORY. Classified as Instrument, Biopsy, Suction (product code FCK), Class II - Special Controls.

Submitted by Biopsys Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biopsys Medical, Inc. devices

FDA 510(k) Submission Details - K944252

510(k) Number K944252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date December 05, 1994
Days to Decision 97 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 130d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCK Device Classification - Class 2, Special Controls

Product Code FCK Instrument, Biopsy, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCK Instrument, Biopsy, Suction

All 7
Devices cleared under the same product code (FCK) and FDA review panel - the closest regulatory comparables to K944252.
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
K061201 · United States Endoscopy Group, Inc. · May 2006
DSNARE, MODEL 00711087
K051637 · United States Endoscopy Group, Inc. · Oct 2005
MEHTA BRONCHIAL BIOSPY DRILL
K954693 · United States Endoscopy Group, Inc. · Oct 1995
SUCTION BIOPSY INSTRUMENT
K895420 · Mill-Rose Laboratory · Feb 1990
WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
K895900 · Wilson-Cook Medical, Inc. · Jan 1990