Cleared Traditional

K892389 - BIOPSY KIT

K892389 is the FDA 510(k) clearance for BIOPSY KIT by I M, Inc.. It is a Class 2 General & Plastic Surgery device (product code LRO) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K892389 · I M, Inc. · General & Plastic Surgery device
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Jul 1989
Decision
101d
Days
Class 2
Risk

K892389 is an FDA 510(k) clearance for the BIOPSY KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on July 17, 1989 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all I M, Inc. devices

Submission Details

510(k) Number K892389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 07, 1989
Decision Date July 17, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 27
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K892389.
CUSTOMED ORTHOPEDIC II
K902888 · Customed, Inc. · Sep 1990
CUSTOMED HIP PACT
K903336 · Customed, Inc. · Aug 1990
DAVIS+GECK VISADUCT KIT
K894685 · Davis & Geck, Inc. · Aug 1989
ALCON SURGICAL PROCEDURE PACKS
K880961 · Alcon Laboratories · Apr 1988
SOFT TISSUE ANCHORING SET KIT
K874439 · Concept, Inc. · Nov 1987
CLOSED CHEST DRAINAGE SET
K871873 · Gish Biomedical, Inc. · Jul 1987