Cleared Traditional

K914215 - SELECTACUT BIOPSY DEVICE

K914215 is an FDA 510(k) clearance for SELECTACUT BIOPSY DEVICE, manufactured by Biomni Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K914215 · Biomni Medical Systems, Inc. · Gastroenterology & Urology device
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Feb 1992
Decision
158d
Days
Class 2
Risk

K914215 is an FDA 510(k) clearance for the SELECTACUT BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Biomni Medical Systems, Inc. (Alpine, US). The FDA issued a Cleared decision on February 24, 1992 after a review of 158 days - an extended review cycle.

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 Biomni Medical Systems, Inc. devices

FDA 510(k) Submission Details - K914215

510(k) Number K914215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date February 24, 1992
Days to Decision 158 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 130d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
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 - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K914215.
BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.
K922939 · C.R. Bard, Inc. · Feb 1993
BIOPSY FORCEPS
K924106 · United States Endoscopy Group, Inc. · Nov 1992
MEADOX SURGIMED BIOPSY GUN III
K922879 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1992
MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE
K914874 · Manan Medical Products, Inc. · Feb 1992
APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
K913098 · Dlp, Inc. · Nov 1991
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · C.R. Bard, Inc. · Aug 1991