Atlas FDA

RENASYS EZ

FDA 510(k) clearance K082426 · decided 2008-09-05

Clearance details

K-number
K082426
Device name
RENASYS EZ
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2008-08-22
Decision date
2008-09-05
Days to decision
14 days
Clearance type
Special
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

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Recalls involving this device

RecordFirmDate
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and recall (Z-0039-2015)Smith & Nephew, Inc.2014-10-08
RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and recall (Z-0040-2015)Smith & Nephew, Inc.2014-10-08
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENAS recall (Z-0041-2015)Smith & Nephew, Inc.2014-10-08
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who wou recall (Z-2688-2014)Smith & Nephew, Inc.2014-09-23

PMA approvals by this applicant

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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
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BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10