510(k) K911158

MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM by Northgate Technologies, Inc. — Product Code LRW

K911158 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code LRW (Scissors, General, Surgical), a Class I device regulated under 21 CFR 878.4800. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
March 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, General, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type