Endo-Leader
FDA 510(k) K954641 · Microsurge, Inc.
510(k) numberK954641
Submission
- Device name
- Endo-Leader
- Applicant
- Microsurge, Inc.
North Attleboro, MA, US - Received
- October 10, 1995
- Decision date
- December 28, 1995
- 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.
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 |
|---|---|---|
| K964109 | Microsurge Laparoscopic Permaclip Cartridge with Implantable ClipFZP · Traditional | 11/27/1996SE |
| K960554 | Detachatip Thoracoscopic ScissorsGEI · Traditional | 03/05/1996SE |
| K955408 | Microsurge Thoracoscopic InstrumentsGCJ · Traditional | 01/31/1996SE |
| K954072 | Microsurge Puncture Close DeviceGCJ · Traditional | 10/26/1995SE |
| K954520 | Microsurge Veress NeedleHET · Traditional | 10/16/1995SE |
| K953121 | Microsurge Thoracoscopic Access SystemGCJ · Traditional | 09/29/1995SE |
| K951230 | Microsurge Bipolar GraspersGEI · Traditional | 06/14/1995SE |
| K933750 | Microsurge Reusable Front End Grasp Devices, ModifGCJ · Traditional | 06/10/1994SE |
| K930355 | Microsurge Suction/Irrigation System CannulasGEI · Traditional | 06/08/1993SE |
| K925830 | Microsurge Suction/Irrigation SystemGEI · Traditional | 05/17/1993SE |
Questions and answers
When was Endo-Leader cleared by the FDA?
Endo-Leader (K954641) received a 510(k) decision of Substantially Equivalent on December 28, 1995, 79 days after the submission was received.
What is the product code of K954641?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.