Atlas FDA

ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM

FDA 510(k) clearance K961069 · decided 1996-05-28

Clearance details

K-number
K961069
Device name
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
Applicant
Arthrocare Corp.
Decision
Substantially Equivalent
Date received
1996-03-18
Decision date
1996-05-28
Days to decision
71 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.