Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge
FDA 510(k) K073671 · Ndo Surgical, Inc.
510(k) numberK073671
Submission
- Device name
- Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge
- Applicant
- Ndo Surgical, Inc.
Mansfield, MA, US - Received
- December 27, 2007
- Decision date
- March 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K072125 | Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentODE · Traditional | 10/18/2007SE |
| K071553 | Endoscopic Plication System; Eps; PlicatorODE · Traditional | 09/18/2007SE |
| K032820 | Modification to Endoscopic Plication SystemODE · Special | 10/23/2003SE |
| K031262 | Endoscopic Plication System, Model 160-00760ODE · Special | 05/23/2003SE |
| K023234 | Endoscopic Plication SystemODE · Traditional | 04/17/2003SE |
Questions and answers
When was Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge cleared by the FDA?
Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge (K073671) received a 510(k) decision of Substantially Equivalent on March 26, 2008, 90 days after the submission was received.
What is the product code of K073671?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.