510(k) K022748

REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS by Medical Device Services — Product Code HET

K022748 is an FDA 510(k) premarket notification submitted by Medical Device Services for the device "REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS". The FDA issued a decision of Substantially Equivalent on October 9, 2002. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Medical Device Services has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2002
Date Received
August 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type