510(k) K913837

MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM by Vision Medical, Inc. — Product Code HQE

K913837 is an FDA 510(k) premarket notification submitted by Vision Medical, Inc. for the device "MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 1991. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Vision Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1991
Date Received
August 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type