Cleared Traditional

K813462 - MADAYAG TYPE NEEDLE

K813462 is an FDA 510(k) clearance for MADAYAG TYPE NEEDLE, manufactured by Ocean Medical Products, Ltd.. 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.

K813462 · Ocean Medical Products, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K813462

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
51d faster than avg
Panel avg: 131d · 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 317
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K813462.
MANAN FRANSEENE NEEDLE
K851831 · Manan Manufacturing Co., Inc. · May 1985
MANAN WESTCOTT NEEDLE
K851837 · Manan Manufacturing Co., Inc. · May 1985
FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP
K851364 · Precision Dynamics Corp. · Apr 1985
BONE BIOPSY SET
K820293 · The Anspach Effort, Inc. · Mar 1982
HEPAFIX BIOPSY NEEDLE SET
K813085 · Burron Medical Products, Inc. · Nov 1981
VANCE PROSTATIC ASPIRATION SET
K811454 · Vance Products, Inc. · Jun 1981