510(k) K914588

GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE by Grieshaber & Co. — Product Code GAW

K914588 is an FDA 510(k) premarket notification submitted by Grieshaber & Co. for the device "GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE". The FDA issued a decision of Substantially Equivalent on June 11, 1992. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Grieshaber & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
October 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type