Atlas FDA

ENDOCOAGULATOR 2001 KLI

FDA 510(k) clearance K895402 · decided 1990-04-26

Clearance details

K-number
K895402
Device name
ENDOCOAGULATOR 2001 KLI
Applicant
Cabot Medical Corp.
Decision
Substantially Equivalent
Date received
1989-09-07
Decision date
1990-04-26
Days to decision
231 days
Clearance type
Traditional
Product code
HGI
Device class
2
Regulation number
884.4120
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Langhorne, PA, US
Third-party review
No
Expedited review
No

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THOMAS MEDICAL ELECTRODES (K022593)Thomas Medical, Inc.2002-11-01
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (K003608)Aesculap, Inc.2001-02-20
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (K002042)New England Medical Corp.2001-02-01
LOOP ELECTRODE, BALL ELECTRODE (K993527)Palm Medical USA, Inc.2000-07-06
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (K993777)R-Group Intl.2000-05-25
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Recalls involving this device

No recalls on record reference this clearance.