510(k) K771302

PFISTER-SCHWARTZ STONE RETRIEVER by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FGO

K771302 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "PFISTER-SCHWARTZ STONE RETRIEVER". The FDA issued a decision of Substantially Equivalent on August 2, 1977. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1977
Date Received
July 15, 1977
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