510(k) K844074

HOBBS MEDICAL POLYPECTOMY SNARE by Hobbs Medical, Inc. — Product Code OCZ

K844074 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "HOBBS MEDICAL POLYPECTOMY SNARE". The FDA issued a decision of Substantially Equivalent on January 3, 1985. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
October 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.