Atlas FDA

COAGULOOP

FDA 510(k) clearance K991314 · decided 1999-06-29

Clearance details

K-number
K991314
Device name
COAGULOOP
Applicant
American Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1999-04-16
Decision date
1999-06-29
Days to decision
74 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Minnetonka, MN, 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
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S002)American Medical Systems, Inc.1998-12-23
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S001)American Medical Systems, Inc.1998-01-09
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012)American Medical Systems, Inc.1995-12-27