Cleared Traditional

K902077 - T19S BIOPSY NEEDLE

K902077 is an FDA 510(k) clearance for T19S BIOPSY NEEDLE, manufactured by Ohio Medical Instrument Co., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K902077 · Ohio Medical Instrument Co., Inc. · Gastroenterology & Urology device
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Jul 1990
Decision
80d
Days
Class 2
Risk

K902077 is an FDA 510(k) clearance for the T19S BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ohio Medical Instrument Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 80 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 Ohio Medical Instrument Co., Inc. devices

FDA 510(k) Submission Details - K902077

510(k) Number K902077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date July 27, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
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 211
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K902077.
APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
K913098 · Dlp, Inc. · Nov 1991
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · C.R. Bard, Inc. · Aug 1991
MEADOX(R) SURGIMED(R) BIOPSY GUN II
K911635 · Meadox Surgimed, Inc. · Jun 1991
MEADOX SURGIMED BIOPSY GUN AND NEEDLE
K902461 · Meadox Surgimed, Inc. · Jul 1990
MAXX 470 CORE BIOPSY GUN
K900082 · Dlp, Inc. · Jun 1990
BIOPSY FORCEPS (NON-RIGID)
K901339 · Applied Medical Technologies · Jun 1990