510(k) K102660

BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS by Smith & Nephew Endoscopy, Inc. — Product Code MBI

K102660 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS". The FDA issued a decision of Substantially Equivalent on December 13, 2010. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2010
Date Received
September 15, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type