FDA 510(k) K243750, SimpleStitch Suturing System, by Envision Endoscopy
FDA 510(k) K243750, SimpleStitch Suturing System, by Envision Endoscopy
| 510(k) Number | K243750 |
| Device Classification Name | Endoscopic Tissue Approximation Device |
| Device Name | SimpleStitch Suturing System |
| Applicant | Envision Endoscopy 204 Second Ave., 2nd Floor Waltham, MA 02451 |
| Regulation Number | 876.15 |
| Classification Product Code | OCW |
| Date Received | 12/05/2024 |
| Decision Date | 04/17/2025 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 510k Review Panel | Gastroenterology/Urology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 2955 |
| Redacted Pages | 2557 |
| Unredacted Pages | 398 |
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