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 a medical device manufactured by Envision Endoscopy. It received FDA 510(k) clearance on 2025-04-17 under approval 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. It is manufactured by Envision Endoscopy. The 510(k) number is K243750.
When was SimpleStitch Suturing System approved by the FDA?
SimpleStitch Suturing System received FDA 510(k) clearance on 2025-04-17, under approval number K243750.
What company makes SimpleStitch Suturing System?
SimpleStitch Suturing System is manufactured by Envision Endoscopy.
What is the FDA product code for SimpleStitch Suturing System?
The FDA product code for SimpleStitch Suturing System is OCW.
Other Devices by Envision Endoscopy
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K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc.
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K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc.
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.