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FDA 510(k)

OverStitch SX Endoscopic Suturing System (ESS)

K-Number: K171886 · 2017-11-15

ApplicantApollo Endosurgery, Inc.
Decision Date2017-11-15
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OverStitch SX Endoscopic Suturing System (ESS) is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2017-11-15 under 510(k) number K171886. 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 OverStitch SX Endoscopic Suturing System (ESS)?

OverStitch SX Endoscopic Suturing System (ESS) is a medical device that received FDA 510(k) clearance on 2017-11-15. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K171886.

When did OverStitch SX Endoscopic Suturing System (ESS) receive FDA 510(k) clearance?

OverStitch SX Endoscopic Suturing System (ESS) received FDA 510(k) clearance on 2017-11-15, under 510(k) number K171886.

Who is the listed applicant for OverStitch SX Endoscopic Suturing System (ESS)?

The FDA 510(k) record lists Apollo Endosurgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OverStitch SX Endoscopic Suturing System (ESS)?

The FDA product code for OverStitch SX Endoscopic Suturing System (ESS) is OCW.

Other records listing Apollo Endosurgery, Inc. 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.

K232544Apollo ESG NXT System, Apollo REVISE NXT SystemK231553OverStitch NXT Endoscopic Suturing SystemK210266OverStitch Sx Endoscopic Suturing SystemK201808X-Tack Endoscopic HeliX Tacking SystemK191439OverStitch 2-0 Polypropylene SutureK181141OverStitch Endoscopic Suturing System and Accessories

View all 7 devices →

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.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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