Cleared Traditional

K033317 - SMARTSTITCH M-CONNECTOR

Also marketed or referenced as:
NEEDLE CASSETTE, OM-8750 AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070

K033317 is the FDA 510(k) clearance for SMARTSTITCH M-CONNECTOR by Opus Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCW) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K033317 · Opus Medical, Inc. · Gastroenterology & Urology device
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Dec 2003
Decision
76d
Days
Class 2
Risk

K033317 is an FDA 510(k) clearance for the SMARTSTITCH M-CONNECTOR, MODEL OM-8700. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Opus Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on December 30, 2003 after a review of 76 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Opus Medical, Inc. devices

Submission Details

510(k) Number K033317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2003
Decision Date December 30, 2003
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 130d · This submission: 76d
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 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 K033317.
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
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
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717 · Smith & Nephew, Inc. · Mar 2000