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FDA 510(k)

HSG CATHETER SET

K-Number: K041094 · 2004-06-17

ApplicantBioteque America, Inc.
Decision Date2004-06-17
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HSG CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque America, Inc.. It received FDA 510(k) clearance on 2004-06-17 under 510(k) number K041094. 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 HSG CATHETER SET?

HSG CATHETER SET is a medical device that received FDA 510(k) clearance on 2004-06-17. The listed applicant is Bioteque America, Inc.. The 510(k) number is K041094.

When did HSG CATHETER SET receive FDA 510(k) clearance?

HSG CATHETER SET received FDA 510(k) clearance on 2004-06-17, under 510(k) number K041094.

Who is the listed applicant for HSG CATHETER SET?

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

What is the FDA product code for HSG CATHETER SET?

The FDA product code for HSG CATHETER SET is LKF.

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Other records listing Bioteque America, 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.

K020628CURELLE, PREFERRED CURELLE, CUTEQ 2.5K013289BIOTEQUE VAGINAL PESSARIESK003380BIOTEQUE VAGINAL DILATORK920633PESSARY FLEXIBLE SILICONE NICHOLSK920747PESSARY FLEXIBLE SILICONE DONUT RINGK933628CYTOLOGY BRUSH

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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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