Cleared Traditional

K915068 - PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER

K915068 is an FDA 510(k) clearance for PLASTIC DISPOSABLE SURGICAL LIGHT HANDL..., manufactured by American Medical Mfg., Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915068 · American Medical Mfg., Inc. · General & Plastic Surgery device
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Feb 1992
Decision
90d
Days
Class 2
Risk

K915068 is an FDA 510(k) clearance for the PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on February 6, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 - K915068

510(k) Number K915068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date February 06, 1992
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTA Light, Surgical, Accessories

All 25
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K915068.
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
K993089 · Deroyal Cardiovascular, Inc. · Oct 1999
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
K954940 · Mdt Biologic Co. · Jan 1996
SATURN LIGHT
K935102 · Burton Medical Products Corp. · Jun 1994
MICROTEK'S SURGICAL LAMP HANDLE & COVER
K901154 · Microbio-Medics, Inc. · Mar 1990
WELCON LIGHT HANDLE
K894397 · Welcon, Inc. · Aug 1989
TC SYSTEM-HANDLE
K890866 · Transmedical Corp. · Mar 1989
K915068 · PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER
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