Atlas FDA

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

FDA 510(k) clearance K981713 · decided 1998-07-31

Clearance details

K-number
K981713
Device name
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
1998-05-15
Decision date
1998-07-31
Days to decision
77 days
Clearance type
Traditional
Product code
MGP
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Largo, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
COLLATEK SHEET (K012995)Biocore Medical Technologies, Inc.2001-10-25
COLLATEK FOAM (K012997)Biocore Medical Technologies, Inc.2001-10-25
LASERSKIN DRESSING (K001508)Fidia Advanced Biopolymers Srl2001-07-25
FASTSEAL CHEST WOUND DRESSING (K990079)Greenfield Medical Technologies, Inc.1999-12-23
SIMPLICARE TRANSPARENT WOUND DRESSING (K991214)Hollister, Inc.1999-10-14
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (K992302)Dermaphylyx, Inc.1999-09-14
GILTECH PLUS TRANSPARENT DRESSING (K992005)Giltech Plus, Inc.1999-09-03
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (K990875)Dermaphylyx, Inc.1999-05-27
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING (K990438)Dermaphylyx, Inc.1999-03-25
MEPITEL NON ADHERENT SILICONE DRESSING (K984371)Molnlycke Health Care, Inc.1999-03-03
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS (K983303)Innovative Technologies , Ltd.1998-12-09
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234)Johnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10