Cleared Traditional

K070151 - INSCOPE TISSUE ANCHORS

K070151 is the FDA 510(k) clearance for INSCOPE TISSUE ANCHORS by Ethicon Endo-Surgery, LLC. It is a Class 2 General & Plastic Surgery device (product code OCW) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K070151 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
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Aug 2007
Decision
211d
Days
Class 2
Risk

K070151 is an FDA 510(k) clearance for the INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEM.... Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 211 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K070151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2007
Decision Date August 15, 2007
Days to Decision 211 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 115d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 36
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K070151.
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · Teleflexmedical, Inc. · Feb 2018
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · Teleflexmedical, Inc. · Oct 2013
AUTOSUTURE PROTACK
K090470 · Covidien · May 2009
OPUS SMARTSTITCH SUTURE DEVICE
K070671 · Arthrocare Corp. · Apr 2007
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · Arthrocare Corp. · Oct 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770 · Ethicon Endo-Surgery, Inc. · Sep 2006