510(k) K860593

ET/RT PAPILLOTOME by Hobbs Medical, Inc. — Product Code KNS

K860593 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "ET/RT PAPILLOTOME". The FDA issued a decision of Substantially Equivalent on July 22, 1986. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1986
Date Received
February 19, 1986
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