Cleared Traditional

K955575 - TECNOL HYDROGEL WOUND DRESSING

K955575 · Tecnol Medical Products, Inc. · General & Plastic Surgery device
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Jan 1996
Decision
41d
Days
-
Risk

K955575 is an FDA 510(k) clearance for the TECNOL HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Tecnol Medical Products, Inc. (Fort Worth, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Tecnol Medical Products, Inc. devices

FDA 510(k) Submission Details - K955575

510(k) Number K955575 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 07, 1995
Decision Date January 17, 1996
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 22
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K955575.
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · B.Braun Medical, Inc. · Apr 1997
DERMAPLEX HYDROGEL WOUND DRESSING
K962513 · Maxxim Medical · Sep 1996
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING
K954664 · Derma Sciences, Inc. · Nov 1995
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)
K954741 · Derma Sciences, Inc. · Nov 1995