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FDA 510(k)

FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1

K-Number: K051294 · 2005-12-21

ApplicantFemspec LLC
Decision Date2005-12-21
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Femspec LLC. It received FDA 510(k) clearance on 2005-12-21 under 510(k) number K051294. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1?

FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 is a medical device that received FDA 510(k) clearance on 2005-12-21. The listed applicant is Femspec LLC. The 510(k) number is K051294.

When did FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 receive FDA 510(k) clearance?

FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 received FDA 510(k) clearance on 2005-12-21, under 510(k) number K051294.

Who is the listed applicant for FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1?

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

What is the FDA product code for FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1?

The FDA product code for FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 is HHK.

Related Clinical Trials

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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Other records listing Femspec LLC 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.

K060320FEMECC ENDOCERVICAL CURETTEK052192FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-IK041757FEMSPEC DISPOSABLE VAGINAL SPECULUM

Related Devices (Code: HHK)

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.

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay MedicalK192534CrossBay Endometrial Tissue Sampler (ETS)Crossbay MedicalK102847DISPOSABLE ENDOMETRIAL SUCTION CURETTEJiangsu Suyun Medical Materials Co., Ltd.K092982THE PANPAC SUCTION CURETTEPanpac Medical Corporation

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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