Atlas FDA

OMNI SPHINCTEROTOME

FDA 510(k) clearance K052051 · decided 2005-08-05

Clearance details

K-number
K052051
Device name
OMNI SPHINCTEROTOME
Applicant
Wilson-Cook Medical, Inc.
Decision
Substantially Equivalent
Date received
2005-07-29
Decision date
2005-08-05
Days to decision
7 days
Clearance type
Special
Product code
KNS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Winston-Salem, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, recall (Z-1598-2009)Cook Endoscopy2009-07-21
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Betha recall (Z-0325-2009)Cook Endoscopy2009-01-05