Cleared Traditional

K943650 - LIVER BIOPSY KIT

K943650 is the FDA 510(k) clearance for LIVER BIOPSY KIT by Manan Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K943650 · Manan Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
29d
Days
Class 2
Risk

K943650 is an FDA 510(k) clearance for the LIVER BIOPSY KIT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on August 26, 1994 after a review of 29 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 Manan Medical Products, Inc. devices

Submission Details

510(k) Number K943650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date August 26, 1994
Days to Decision 29 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
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 173
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K943650.
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
TECHNA-CUT ASPIRATION NEEDLE
K943651 · Manan Medical Products, Inc. · Sep 1994
WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE
K942630 · Mill-Rose Laboratory · Jul 1994
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