Atlas FDA

ENDOLAP RESECTOSCOPE ROLLER ELECTRODE

FDA 510(k) clearance K974515 · decided 1997-12-22

Clearance details

K-number
K974515
Device name
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
Applicant
Endolap, Inc.
Decision
Substantially Equivalent
Date received
1997-12-02
Decision date
1997-12-22
Days to decision
20 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Orlando, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.