Atlas FDA

LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR

FDA 510(k) clearance K905747 · decided 1991-09-17

Clearance details

K-number
K905747
Device name
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
Applicant
Coopervision Surgical
Decision
Substantially Equivalent
Date received
1990-12-24
Decision date
1991-09-17
Days to decision
267 days
Clearance type
Traditional
Product code
HGI
Device class
2
Regulation number
884.4120
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Mountain View, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 recall (Z-0484-2015)CooperSurgical, Inc.2014-12-02

PMA approvals by this applicant

RecordFirmDate
HYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE (N17511/S015)Coopervision Surgical2008-05-14
HYSKON HYSTEROSCOPY FLUID (N17511/S014)Coopervision Surgical2001-08-17
HYSKON HYSTEROSCOPY FLUID (N17511/S013)Coopervision Surgical2000-02-09
HYSKON (32% DEXTRAN 70) (N17511/S012)Coopervision Surgical1997-12-30
HYSKON (32% DEXTRAN 70) (N17511/S010)Coopervision Surgical1995-07-18
HYSKON (32% DEXTRAN 70) (N17511/S011)Coopervision Surgical1995-07-18
HYSKON (32% DEXTRAN 70) (N17511/S009)Coopervision Surgical1992-01-24
HYSKON (32% DEXTRAN 70) (N17511/S008)Coopervision Surgical1987-08-17