510(k) K962676

DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE by United States Endoscopy Group, Inc. — Product Code FGO

K962676 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE". The FDA issued a decision of Substantially Equivalent on October 4, 1996. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1996
Date Received
July 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type