Cleared Traditional

K933448 - MANAN ADAPTER FOR BIP BIOPSY DEVICE

K933448 is an FDA 510(k) clearance for MANAN ADAPTER FOR BIP BIOPSY DEVICE, manufactured by Manan Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K933448 · Manan Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
121d
Days
Class 2
Risk

K933448 is an FDA 510(k) clearance for the MANAN ADAPTER FOR BIP BIOPSY DEVICE. 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 November 12, 1993 after a review of 121 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 Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K933448

510(k) Number K933448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1993
Decision Date November 12, 1993
Days to Decision 121 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
10d faster than avg
Panel avg: 131d · This submission: 121d
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 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K933448.
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
ACECUT SUTOMATIC BIOPSY SYSTEM
K930201 · Meadox Surgimed, Inc. · Jun 1993
EMS BIOPSY INSTRUMENT
K930083 · Engineered Medical Systems · Apr 1993
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K930241 · Olympus Corp. · Apr 1993