510(k) K761242

TEFLON COATED RESECTOSCOPE SHEATH by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FJL

K761242 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "TEFLON COATED RESECTOSCOPE SHEATH". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. 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
December 16, 1976
Date Received
December 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type