Cleared Traditional

K981713 - CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0

K981713 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
77d
Days
-
Risk

K981713 is an FDA 510(k) clearance for the CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUN.... Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on July 31, 1998 after a review of 77 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K981713

510(k) Number K981713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1998
Decision Date July 31, 1998
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K981713.
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
K974890 · Acutek Adhesive Specialties, Inc. · Oct 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
K974892 · Acutek Adhesive Specialties, Inc. · Oct 1998
BTF THIN FILM WOUND DRESSING
K982939 · Bioderm, Inc. · Oct 1998
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING
K981753 · Innovative Technologies , Ltd. · Jun 1998
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 1998
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
K974520 · Innovative Technologies (Us), Inc. · Feb 1998