Cleared Traditional

K822401 - ST. MARK'S RECTAL BIOPSY FORCEPS

K822401 is the FDA 510(k) clearance for ST. MARK'S RECTAL BIOPSY FORCEPS by Keymed, Inc.. It is a Class 1 Gastroenterology & Urology device (product code KOA) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K822401 · Keymed, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 1982
Decision
17d
Days
Class 1
Risk

K822401 is an FDA 510(k) clearance for the ST. MARK'S RECTAL BIOPSY FORCEPS. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Keymed, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 Keymed, Inc. devices

Submission Details

510(k) Number K822401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1982
Decision Date August 27, 1982
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 24
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K822401.
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VASOVASOSTOMY STABILIZER PLATFORM DEV
K811223 · Biomet, Inc. · May 1981
CIRCLE NEPHROSTOMY TUBE INTRODUCER
K810533 · American V. Mueller · Mar 1981
FLEXIBLE CUTTING SCISSORS
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