510(k) K872384

SIDE CUTTING PARALLEL ACTION PLIERS by Med-Tool, Inc. — Product Code HTC

K872384 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "SIDE CUTTING PARALLEL ACTION PLIERS". The FDA issued a decision of Substantially Equivalent on July 2, 1987. The device falls under product code HTC (Pliers, Surgical), a Class I device regulated under 21 CFR 878.4800. Med-Tool, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1987
Date Received
June 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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