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FDA 510(k)

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER

K-Number: K000026 · 2000-03-31

ApplicantApple Medical Corp.
Decision Date2000-03-31
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Apple Medical Corp.. It received FDA 510(k) clearance on 2000-03-31 under 510(k) number K000026. 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 APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER?

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER is a medical device that received FDA 510(k) clearance on 2000-03-31. The listed applicant is Apple Medical Corp.. The 510(k) number is K000026.

When did APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER receive FDA 510(k) clearance?

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER received FDA 510(k) clearance on 2000-03-31, under 510(k) number K000026.

Who is the listed applicant for APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER?

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

What is the FDA product code for APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER?

The FDA product code for APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER is HHK.

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Other records listing Apple Medical Corp. 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.

K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORK041131APPLE MEDICAL OB MOBIUS ELASTIC RETRACTORK014005APPLE MEDICAL MOBIUS ELASTIC RETRACTORK970788PNEUMO-MATIC INSUFFLATION NEEDLEK961460LWEET CONE BIOPSY INSTRUMENT

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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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