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FDA 510(k)

ALLY II Uterine Positioning System™ (UPS)

K-Number: K223064 · 2022-10-28

ApplicantCooperSurgical, Inc.
Decision Date2022-10-28
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ALLY II Uterine Positioning System™ (UPS) is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K223064. 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 ALLY II Uterine Positioning System™ (UPS)?

ALLY II Uterine Positioning System™ (UPS) is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K223064.

When did ALLY II Uterine Positioning System™ (UPS) receive FDA 510(k) clearance?

ALLY II Uterine Positioning System™ (UPS) received FDA 510(k) clearance on 2022-10-28, under 510(k) number K223064.

Who is the listed applicant for ALLY II Uterine Positioning System™ (UPS)?

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

What is the FDA product code for ALLY II Uterine Positioning System™ (UPS)?

The FDA product code for ALLY II Uterine Positioning System™ (UPS) is LKF.

Other records listing CooperSurgical, 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.

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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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