510(k) K851922

URETERAL STONE DISLODGER by Inter-Med Corp. — Product Code FFL

K851922 is an FDA 510(k) premarket notification submitted by Inter-Med Corp. for the device "URETERAL STONE DISLODGER". The FDA issued a decision of Substantially Equivalent on August 2, 1985. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Inter-Med Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1985
Date Received
May 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Basket, Ureteral, Metal
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type