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FDA 510(k)

SimpleStitch Suturing System

K-Number: K243750 · 2025-04-17

ApplicantEnvision Endoscopy
Decision Date2025-04-17
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SimpleStitch Suturing System is the device name listed in this FDA 510(k) record. The listed applicant is Envision Endoscopy. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K243750. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimpleStitch Suturing System?

SimpleStitch Suturing System is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Envision Endoscopy. The 510(k) number is K243750.

When did SimpleStitch Suturing System receive FDA 510(k) clearance?

SimpleStitch Suturing System received FDA 510(k) clearance on 2025-04-17, under 510(k) number K243750.

Who is the listed applicant for SimpleStitch Suturing System?

The FDA 510(k) record lists Envision Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SimpleStitch Suturing System?

The FDA product code for SimpleStitch Suturing System is OCW.

Other records listing Envision Endoscopy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)

Related Devices (Code: OCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.K201744Su2ura Approximation DeviceAnchora Medical, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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