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FDA 510(k)

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26

K-Number: K001555 · 2000-08-02

ApplicantSims Portex , Ltd.
Decision Date2000-08-02
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex , Ltd.. It received FDA 510(k) clearance on 2000-08-02 under 510(k) number K001555. 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 SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26?

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 is a medical device that received FDA 510(k) clearance on 2000-08-02. The listed applicant is Sims Portex , Ltd.. The 510(k) number is K001555.

When did SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 receive FDA 510(k) clearance?

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 received FDA 510(k) clearance on 2000-08-02, under 510(k) number K001555.

Who is the listed applicant for SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26?

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

What is the FDA product code for SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26?

The FDA product code for SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 is HHK.

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Other records listing Sims Portex , Ltd. 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.

K012277PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILEK012068WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733SK000628WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

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

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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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