Cleared Special

K000717 - SMITH & NEPHEW SUTURELOK

K000717 is the FDA 510(k) clearance for SMITH & NEPHEW SUTURELOK by Smith & Nephew, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCW) cleared through the Special 510(k) pathway after a 27-day FDA review.

K000717 · Smith & Nephew, Inc. · Gastroenterology & Urology device
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Mar 2000
Decision
27d
Days
Class 2
Risk

K000717 is an FDA 510(k) clearance for the SMITH & NEPHEW SUTURELOK, MODEL 7207321. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 30, 2000 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K000717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2000
Decision Date March 30, 2000
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 37
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K000717.
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770 · Ethicon Endo-Surgery, Inc. · Sep 2006
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · Ethicon Endo-Surgery, Inc. · Dec 2003
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
K002398 · Ethicon Endo-Surgery, Inc. · Nov 2000
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815 · Ethicon Endo-Surgery, Inc. · May 1998
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
K973313 · Innovasive Devices, Inc. · Dec 1997
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
K970720 · Ethicon Endo-Surgery, Inc. · Jun 1997