510(k) K902949

CORPAK GRASPING FORCEPS by Corpak Co. — Product Code OCZ

K902949 is an FDA 510(k) premarket notification submitted by Corpak Co. for the device "CORPAK GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on August 30, 1990. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Corpak Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1990
Date Received
July 5, 1990
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.