Cleared Traditional

K822278 - ENT FORCEPS

K822278 is the FDA 510(k) clearance for ENT FORCEPS by Kelleher Corp.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K822278 · Kelleher Corp. · General & Plastic Surgery device
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Aug 1982
Decision
29d
Days
Class 1
Risk

K822278 is an FDA 510(k) clearance for the ENT FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on August 27, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: 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 Kelleher Corp. devices

Submission Details

510(k) Number K822278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1982
Decision Date August 27, 1982
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEN Forceps, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEN Forceps, General & Plastic Surgery

All 53
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K822278.
DISSECTING TWEEZER #283-72PCS. SS 410
K851170 · The Huxley Instrument Corp. · Apr 1985
FORCEPS & HAMOSTATS
K844062 · I M, Inc. · Jan 1985
DISPOSABLE GRASPING FORCEPS
K822491 · Van-Tec, Inc. · Sep 1982
ROCHESTER PEAN FORCEPS
K821248 · Conphar, Inc. · May 1982
THUMB DRESSING FORCEPS
K821267 · Conphar, Inc. · May 1982
HALSTEAD MOSQUITO FORCEPS
K821274 · Conphar, Inc. · May 1982