Cleared Traditional

K935814 - MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE

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

K935814 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K935814

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
29d faster than avg
Panel avg: 131d · This submission: 102d
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 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K935814.
BIOPSY NEEDLE AND HOUSING
K942639 · Biopsys Medical, Inc. · Jul 1994
BIP MULTI MODIFICATION
K934371 · Bip USA, Inc. · Apr 1994
BIOPSY NEEDLE AND HOUSING
K941549 · Biopsys Medical, Inc. · Apr 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
ACECUT SUTOMATIC BIOPSY SYSTEM
K930201 · Meadox Surgimed, Inc. · Jun 1993
K935814 · MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE
Download PDF FDA Summary Boston Scientific Corp