Atlas FDA

RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS

FDA 510(k) clearance K110647 · decided 2011-06-22

Clearance details

K-number
K110647
Device name
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2011-03-07
Decision date
2011-06-22
Days to decision
107 days
Clearance type
Traditional
Product code
OMP
Device class
2
Regulation number
878.4780
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
St. Petersburg, FL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Smith & Nephew

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
ConvaVAC™ Negative Pressure Wound Therapy System (K253263)Convatec Limited, Gdc Building2026-06-24
CURASYS 2 (EMDN0003) (K253199)CG Bio Co., Ltd.2026-06-23
RENASYS EDGE (66803126) (K260646)Smith & Nephew Medical, Ltd.2026-05-27
Nisus NPWT Canister 500-mL (CPC-500) (K261291)Cork Medical2026-05-21
Wound Geni NPWT System (K254019)Bechtel Medical, Inc.2026-05-04
Genadyne ASTRA NPWT (K253429)Genadyne Biotechnologies, Inc.2026-03-12
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (K250586)Deroyal Industries, Inc.2025-11-21
extriCARE® 1000 Negative Pressure Wound Therapy System (K251646)Alleva Medical Devices2025-10-03
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (K251826)Smith & Nephew Medical, Ltd.2025-09-11
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (K243187)Cork Medical2025-06-27
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port (K243576)Smith & Nephew Medical, Ltd.2025-02-18
Genadyne DUO NPWT (K233614)Genadyne Biotechnologies, Inc.2024-12-23

Recalls involving this device

RecordFirmDate
Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are us recall (Z-1157-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and recall (Z-1158-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing recall (Z-1159-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and recall (Z-1160-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The recall (Z-1161-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The REN recall (Z-1162-2014)Smith & Nephew Inc.2014-03-10

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