Cleared Traditional

K915064 - DISPOSABLE CAUTERY ABRASIVE PAD

K915064 is an FDA 510(k) clearance for DISPOSABLE CAUTERY ABRASIVE PAD, manufactured by American Medical Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K915064 · American Medical Mfg., Inc. · General & Plastic Surgery device
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Mar 1992
Decision
124d
Days
Class 1
Risk

K915064 is an FDA 510(k) clearance for the DISPOSABLE CAUTERY ABRASIVE PAD. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on March 11, 1992 after a review of 124 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K915064

510(k) Number K915064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date March 11, 1992
Days to Decision 124 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 115d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

KDC Device Classification - Class 1, General Controls

Product Code KDC Instrument, Surgical, Disposable
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 - KDC Instrument, Surgical, Disposable

All 58
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K915064.
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K936226 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1994
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K920263 · Phoenix Instruments Div. · May 1992
INSTRUMENT ORGANIZER
K914960 · O.R. Concepts, Inc. · Feb 1992
SHUR-GRIP
K912834 · Inman Medical Corp. · Jul 1991
DISPOSABLE INTRODUCER SHEATH
K910079 · Applied Vascular Devices, Inc. · Feb 1991
K915064 · DISPOSABLE CAUTERY ABRASIVE PAD
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