Atlas FDA

RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS

FDA 510(k) clearance K102781 · decided 2011-01-11

Clearance details

K-number
K102781
Device name
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
Applicant
Olympus Winter & Ibe GmbH
Decision
Substantially Equivalent
Date received
2010-09-27
Decision date
2011-01-11
Days to decision
106 days
Clearance type
Special
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Center Valley, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for en recall (Z-2413-2023)Olympus Corporation of the Americas2023-08-17