Atlas FDA

SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273

FDA 510(k) clearance K012724 · decided 2001-11-08

Clearance details

K-number
K012724
Device name
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2001-08-14
Decision date
2001-11-08
Days to decision
86 days
Clearance type
Traditional
Product code
LYK
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Andover, MA, US
Third-party review
No
Expedited review
No

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GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (K964061)W. L. Gore & Associates, Inc.1997-02-20
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ (K952638)Baxter Edwards1995-07-28
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (K951721)Applied Medical Resources1995-07-11
APPLIED MEDICAL OPTICAL VALVULOTOME (K945591)Applied Medical Resources1995-02-10
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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