Cleared Traditional

K935814 - MICROVASIVE/MEDITECH ASAP(TM) 14G BIOPS...

K935814 is the FDA 510(k) clearance for MICROVASIVE/MEDITECH ASAP(TM) 14G BIOPS... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K935814 · Boston Scientific Corp · Gastroenterology & Urology device
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Mar 1994
Decision
102d
Days
Class 2
Risk

K935814 is an FDA 510(k) clearance for the MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on March 14, 1994 after a review of 102 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 Boston Scientific Corp devices

Submission Details

510(k) Number K935814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date March 14, 1994
Days to Decision 102 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 130d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 156
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K935814.
TECHNA-CUT ASPIRATION NEEDLE
K943651 · Manan Medical Products, Inc. · Sep 1994
LIVER BIOPSY KIT
K943650 · Manan Medical Products, Inc. · Aug 1994
WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE
K942630 · Mill-Rose Laboratory · Jul 1994
MANAN ADAPTER FOR BARD BIOPTY SYSTEM
K940365 · Manan Medical Products, Inc. · Feb 1994
MANAN ADAPTER FOR BIP BIOPSY DEVICE
K933448 · Manan Medical Products, Inc. · Nov 1993
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K930241 · Olympus Corp. · Apr 1993