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Smartstitch M-Connector Model OM-8700, Needle Cassette OM-8750, Autocuff System Instrument Set OM-9070

by Opus Medical, Inc.

510(k) K033317

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033317 Date30 Dec 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OCW
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Smartstitch M-Connector, Needle Cassette, and Autocuff System Instrument Set are endoscopic tissue approximation devices. These components are indicated for the placement of braided polyester suture through soft tissue in endoscopic and other limited access procedures.

This system is supplied as a single-use device and is not made with natural rubber latex. It has received FDA 510(k) clearance under the regulation number 876.1500.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Smartstitch system?

    The Smartstitch M-Connector, Needle Cassette, and Autocuff System are endoscopic tissue approximation devices designed for the placement of braided polyester suture through soft tissue during endoscopic or other limited access surgical procedures.

  • Is the Smartstitch system intended for single-use or reuse?

    The system is supplied as a single-use device. This design ensures that each procedure is performed with sterile, unused components to maintain patient safety and prevent cross-contamination.

  • Are the Smartstitch components made with natural rubber latex?

    The components are not made with natural rubber latex, which helps reduce the risk of allergic reactions for patients with latex sensitivities.

  • What is the regulatory status of these devices?

    The Smartstitch M-Connector (OM-8700), Needle Cassette (OM-8750), and Autocuff System Instrument Set (OM-9070) have received FDA 510(k) clearance under regulation number 876.1500.