Cleared Traditional

K954940 - MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE

K954940 is an FDA 510(k) clearance for MDT STERIGRIP DISPOSABLE, manufactured by Mdt Biologic Co.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K954940 · Mdt Biologic Co. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
79d
Days
Class 2
Risk

K954940 is an FDA 510(k) clearance for the MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Mdt Biologic Co. (Rochester, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 79 days - a notably fast clearance cycle.

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: 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 - K954940

510(k) Number K954940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date January 17, 1996
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
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 K954940.
KSEA SCB MEDIA CONTROL
K020640 · KARL STORZ Endoscopy-America, Inc. · May 2002
DISPOSABLE LIGHT HANDLE AND ADAPTOR
K020304 · Aspen Surgical Products, Inc. · Feb 2002
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
K993089 · Deroyal Cardiovascular, Inc. · Oct 1999
SATURN LIGHT
K935102 · Burton Medical Products Corp. · Jun 1994
PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER
K915068 · American Medical Mfg., Inc. · Feb 1992
MICROTEK'S SURGICAL LAMP HANDLE & COVER
K901154 · Microbio-Medics, Inc. · Mar 1990
K954940 · MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
Download PDF FDA Summary Mdt Biologic Co.