Device class
Class II
Regulation 876.1500
Total clearances
9
2020-03-26 → 2026-02-13
Definition
What is Endoscopic Tissue Approximation Device
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Endo Tools Therapeutics S.A. |
2 |
1 |
2026-02-13 |
|
Apollo Endosurgery, Inc.
|
2 |
0 |
2023-06-29 |
|
Health Value Creation B.V., Trading AS Corporis Medical |
1 |
0 |
2023-08-31 |
|
Medeon Biodesign, Inc. |
1 |
0 |
2020-03-26 |
|
Envision Endoscopy |
1 |
0 |
2025-04-17 |
|
Covidien
|
1 |
0 |
2023-09-08 |
|
Anchora Medical, Ltd. |
1 |
0 |
2021-06-17 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 43405 |
CPT
|
— |
Medium
|
Endoscopic suturing/tissue approximation procedure code |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Medium
|
Endoscopic accessory device supply |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-02-13 |
K252400 |
Endo Tools Therapeutics S.A.
|
Endomina EZFuse system |
| 2025-04-17 |
K243750 |
Envision Endoscopy
|
SimpleStitch Suturing System |
| 2023-09-08 |
K231240 |
Covidien
|
MaxTack Motorized Fixation Device |
| 2023-08-31 |
K213271 |
Health Value Creation B.V., Trading AS Corporis Medical
|
MedicloseTM System |
| 2023-06-29 |
K231553 |
Apollo Endosurgery, Inc.
|
OverStitch NXT Endoscopic Suturing System |
| 2021-12-07 |
K211309 |
Endo Tools Therapeutics S.A.
|
endomina system |
| 2021-06-17 |
K201744 |
Anchora Medical, Ltd.
|
Su2ura Approximation Device |
| 2021-03-02 |
K210266 |
Apollo Endosurgery, Inc.
|
OverStitch Sx Endoscopic Suturing System |
| 2020-03-26 |
K193652 |
Medeon Biodesign, Inc.
|
AbClose - Port Site Closure Device |