Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070
FDA 510(k) K033317 · Opus Medical, Inc.
510(k) numberK033317
Submission
- Device name
- Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070
- Applicant
- Opus Medical, Inc.
San Juan Capistrano, CA, US - Received
- October 15, 2003
- Decision date
- December 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Other 510(k)s with product code OCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252400 | Endomina EZFuse systemOCW · Traditional | Endo Tools Therapeutics S.A. | 02/13/2026SE |
| K243750 | SimpleStitch Suturing SystemOCW · Traditional | Envision Endoscopy | 04/17/2025SE |
| K231240 | MaxTack Motorized Fixation DeviceOCW · Traditional | Covidien | 09/08/2023SE |
| K213271 | MedicloseTM SystemOCW · Traditional | Health Value Creation B.V., Trading AS Corporis… | 08/31/2023SE |
| K231553 | OverStitch NXT Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 06/29/2023SE |
| K211309 | endomina systemOCW · Traditional | Endo Tools Therapeutics S.A. | 12/07/2021SE |
| K201744 | Su2ura Approximation DeviceOCW · Traditional | Anchora Medical, Ltd. | 06/17/2021SE |
| K210266 | OverStitch Sx Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 03/02/2021SE |
| K193652 | AbClose - Port Site Closure DeviceOCW · Traditional | Medeon Biodesign, Inc. | 03/26/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | Apollo Endosurgery | 08/29/2019SE |
More from Apollo Endosurgery
| 510(k) | Device | Decision |
|---|---|---|
| K042584 | Opus Minimagnum Anchor with InserterHWC · Traditional | 12/14/2004SE |
| K042914 | Opus Magnum Knotless Anchor with Inserter HandleMBI · Special | 11/12/2004SE |
| K042031 | Opus Speedstitch Suture DeviceGAT · Traditional | 10/19/2004SE |
| K041440 | Opus Magnum Anchor with InserterMBI · Special | 06/25/2004SE |
| K030170 | Reusable Smartstitch Suture Device, Models OM-8007, OM-8500OCW · Traditional | 07/28/2003SE |
| K031083 | Opus Magnum Implant System, Model OM-1500HTY · Traditional | 06/12/2003SE |
| K030235 | F1 Diode Laser SystemGEX · Traditional | 04/23/2003SE |
| K023843 | Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and…OCW · Traditional | 02/14/2003SE |
| K022229 | Smartstitch Suture Device, Model OM-8500OCW · Traditional | 09/06/2002SE |
| K020172 | Opus Magnum Anchor & Instrument SetMBI · Abbreviated | 07/22/2002SE |
Questions and answers
When was Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070 cleared by the FDA?
Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070 (K033317) received a 510(k) decision of Substantially Equivalent on December 30, 2003, 76 days after the submission was received.
What is the product code of K033317?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.