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FDA 510(k)

ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM

K-Number: K061770 · 2006-09-25

ApplicantEthicon Endo-Surgery, Inc.
Decision Date2006-09-25
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2006-09-25 under 510(k) number K061770. 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 ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM?

ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-25. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K061770.

When did ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM receive FDA 510(k) clearance?

ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM received FDA 510(k) clearance on 2006-09-25, under 510(k) number K061770.

Who is the listed applicant for ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM?

The FDA 510(k) record lists Ethicon Endo-Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM?

The FDA product code for ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM is OCW.

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Other records listing Ethicon Endo-Surgery, Inc. as applicant

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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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