Cleared Traditional

K930201 - ACECUT SUTOMATIC BIOPSY SYSTEM

K930201 is the FDA 510(k) clearance for ACECUT SUTOMATIC BIOPSY SYSTEM by Meadox Surgimed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K930201 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
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Jun 1993
Decision
146d
Days
Class 2
Risk

K930201 is an FDA 510(k) clearance for the ACECUT SUTOMATIC BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 146 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 Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K930201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date June 09, 1993
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
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 165
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K930201.
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE
K935814 · Boston Scientific Corp · Mar 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
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