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FDA 510(k)

H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005

K-Number: K013972 · 2001-12-17

ApplicantAckard Laboratories
Decision Date2001-12-17
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 is the device name listed in this FDA 510(k) record. The listed applicant is Ackard Laboratories. It received FDA 510(k) clearance on 2001-12-17 under 510(k) number K013972. 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 H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005?

H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 is a medical device that received FDA 510(k) clearance on 2001-12-17. The listed applicant is Ackard Laboratories. The 510(k) number is K013972.

When did H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 receive FDA 510(k) clearance?

H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 received FDA 510(k) clearance on 2001-12-17, under 510(k) number K013972.

Who is the listed applicant for H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005?

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

What is the FDA product code for H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005?

The FDA product code for H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 is LKF.

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Other records listing Ackard Laboratories 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.

K852990PAO VALUE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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