510(k) K022268

HORIZONS REUSABLE POLYPECTOMY SNARES by Horizons Intl. Corp. — Product Code FDI

K022268 is an FDA 510(k) premarket notification submitted by Horizons Intl. Corp. for the device "HORIZONS REUSABLE POLYPECTOMY SNARES". The FDA issued a decision of Substantially Equivalent on October 25, 2002. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Horizons Intl. Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
July 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type