510(k) K931764

HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES by Olympus Corp. — Product Code HIH

K931764 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES". The FDA issued a decision of Substantially Equivalent on June 8, 1994. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1994
Date Received
April 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type