Cleared Traditional

K945573 - BIOPSY DEVICE ACCESSORY

K945573 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 KNW cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K945573 · Biopsys Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Dec 1994
Decision
25d
Days
Class 2
Risk

K945573 is an FDA 510(k) clearance for the BIOPSY DEVICE ACCESSORY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Biopsys Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 25 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biopsys Medical, Inc. devices

FDA 510(k) Submission Details - K945573

510(k) Number K945573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date December 09, 1994
Days to Decision 25 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
105d faster than avg
Panel avg: 130d · This submission: 25d
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 K945573.
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