Cleared Traditional

K822569 - TYMPANOPLASTY & SKIN DISSECTORS

K822569 is an FDA 510(k) clearance for TYMPANOPLASTY & SKIN DISSECTORS, manufactured by Kelleher Corp.. The device is a Class 1 General & Plastic Surgery device with product code GDI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K822569 · Kelleher Corp. · General & Plastic Surgery device
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Oct 1982
Decision
43d
Days
Class 1
Risk

K822569 is an FDA 510(k) clearance for the TYMPANOPLASTY & SKIN DISSECTORS. Classified as Dissector, Surgical, General & Plastic Surgery (product code GDI), Class I - General Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1982 after a review of 43 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.

FDA 510(k) Submission Details - K822569

510(k) Number K822569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date October 06, 1982
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

GDI Device Classification - Class 1, General Controls

Product Code GDI Dissector, Surgical, 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 - GDI Dissector, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GDI) and FDA review panel - the closest regulatory comparables to K822569.
DISPOSABLE EXTERNAL CLAMPS
K896383 · Galenica Enterprises, Inc. · Dec 1989
HEPATIC PARENCHYMAL SUCTION DISSECTOR
K850288 · Beecher Medical Diagnostic Instrumentation · Mar 1985
ROUND-BEEHIVE- DISSECTORS 3/8
K831912 · Ormed Mfg., Inc. · Oct 1983
FIELD SUCTION DISSECTOR
K803292 · V. Mueller O.V. Baxter Healthcare Corp. · Jan 1981
DISPOSABLE SPECIALITY SPONGES
K791870 · Carwild Corp. · Nov 1979
TEW BYPASS INSTRUMENTS & DISSECTING KIT
K791703 · Edward Weck, Inc. · Oct 1979
K822569 · TYMPANOPLASTY & SKIN DISSECTORS
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