Cleared Traditional

K953880 - BIOPSY NEEDLE

K953880 is an FDA 510(k) clearance for BIOPSY NEEDLE, 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 21-day FDA review.

K953880 · Biopsys Medical, Inc. · Gastroenterology & Urology device
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Sep 1995
Decision
21d
Days
Class 2
Risk

K953880 is an FDA 510(k) clearance for the BIOPSY NEEDLE. 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 September 8, 1995 after a review of 21 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 - K953880

510(k) Number K953880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1995
Decision Date September 08, 1995
Days to Decision 21 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
109d faster than avg
Panel avg: 130d · This submission: 21d
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 K953880.
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · C.R. Bard, Inc. · Jul 1996
18 GAUGE TRU-CUT BIOPSY NEEDLE
K960509 · Baxter Healthcare Corp · Apr 1996
AUTOMATED TRU-CUT BIOPSY DEVICE
K954529 · Baxter Healthcare Corp · Dec 1995
URESIL INTRODUCING NEEDLE
K953923 · Uresil Corp. · Sep 1995
MANAN SUPER-CORE BIOPSY NEEDLE
K950732 · Manan Medical Products, Inc. · Mar 1995
MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE
K944837 · Medical Device Technologies, Inc. · Oct 1994