510(k) K896426

PORGES SPHINCTEROTOMES by Porges Corp. — Product Code KNS

K896426 is an FDA 510(k) premarket notification submitted by Porges Corp. for the device "PORGES SPHINCTEROTOMES". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Porges Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
November 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type