SimpleStitch Suturing System— 510(k) K243750

Name: FDA 510(k) clearance K243750
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Substantially Equivalent

Envision Endoscopy

FDA 510(k) clearance K243750 for SimpleStitch Suturing System, Substantially Equivalent on 2025-04-17. Applicant: Envision Endoscopy. Device class: 2.

Clearance details

Applicant: Envision Endoscopy
Product code: Code OCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-05
Decision date: 2025-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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K213271 — MedicloseTM System2023-08-31
K231553 — OverStitch NXT Endoscopic Suturing System2023-06-29
K211309 — endomina system2021-12-07

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K242923 — SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)2024-12-20

Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.