Cleared Traditional

K813462 - MADAYAG TYPE NEEDLE

K813462 is the FDA 510(k) clearance for MADAYAG TYPE NEEDLE by Ocean Medical Products, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K813462 · Ocean Medical Products, Ltd. · Gastroenterology & Urology device
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Mar 1982
Decision
80d
Days
Class 2
Risk

K813462 is an FDA 510(k) clearance for the MADAYAG TYPE NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ocean Medical Products, Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982 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 Ocean Medical Products, Ltd. devices

Submission Details

510(k) Number K813462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1981
Decision Date March 01, 1982
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 111
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K813462.
SOFT TISSUE BIOPSY NEEDLE
K870785 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · Travenol Laboratories, S.A. · Feb 1986
53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN
K851798 · Artiberia · May 1985
HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM
K781038 · Quinton, Inc. · Aug 1978
PROSTATE BIOPSY NEEDLE
K770122 · Cook, Inc. · Jan 1977