Atlas FDA

EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE

FDA 510(k) clearance K953983 · decided 1996-10-02

Clearance details

K-number
K953983
Device name
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
Applicant
Richard Wolf Medical Instruments Corp.
Decision
Substantially Equivalent
Date received
1995-08-23
Decision date
1996-10-02
Days to decision
406 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Vernon Hills, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002)Richard Wolf Medical Instruments Corp.2016-10-14
HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001)Richard Wolf Medical Instruments Corp.1998-03-12
HULKA CLIP FOR TUBAL OCCLUSION (P870080)Richard Wolf Medical Instruments Corp.1996-09-05
RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013)Richard Wolf Medical Instruments Corp.1991-09-09