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FDA 510(k)

AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR

K-Number: K930867 · 1994-07-25

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1994-07-25
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1994-07-25 under 510(k) number K930867. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR?

AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K930867.

When did AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR receive FDA 510(k) clearance?

AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR received FDA 510(k) clearance on 1994-07-25, under 510(k) number K930867.

Who is the listed applicant for AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR?

The FDA product code for AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR is LKF.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

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Related Devices (Code: LKF)

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.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, 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.

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