Cleared Traditional

K922161 - GRICE SOFT TISSUE BIOPSY KIT

K922161 is the FDA 510(k) clearance for GRICE SOFT TISSUE BIOPSY KIT by Ideal Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K922161 · Ideal Medical, Inc. · Gastroenterology & Urology device
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Oct 1992
Decision
159d
Days
Class 2
Risk

K922161 is an FDA 510(k) clearance for the GRICE SOFT TISSUE BIOPSY KIT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on October 13, 1992 after a review of 159 days - an extended review 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: 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 Ideal Medical, Inc. devices

Submission Details

510(k) Number K922161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date October 13, 1992
Days to Decision 159 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 130d · This submission: 159d
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 112
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K922161.
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
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · C.R. Bard, Inc. · Aug 1991
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · Boston Scientific Corp · Feb 1989
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
K884900 · Siemens Medical Solutions USA, Inc. · Jan 1989