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)
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.

View all Mdt Biologic Co. devices

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 7
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K954940.
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K780162 · Cavitron Corp. · Mar 1978