Monoject Endometrial Sampling Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K790875 ↗

FDA Product Code

HHK

Device Class

Class II

Regulation

21 CFR Part 884.1175

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K801372 Active Cleared 26 Jun 1980

• Argyle Aspr-Care Closed Suction System

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• Labcer Fibrinogen Assay Kit & Calibr.

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• Monoject(R) Trace Element Blood Collection Tube

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  FDA 510(k) K883320 Active Cleared 27 Sep 1988

• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

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See all devices from Sherwood Medical Co. →

• What is the Monoject Endometrial Sampling Kit used for?

  The device is designed for the collection of endometrial tissue samples, functioning as a curette and suction system in obstetrics and gynecology procedures to obtain tissue for diagnostic evaluation.

• How is the Monoject Endometrial Sampling Kit supplied?

  It is supplied as a complete kit that includes the curette, suction components, and necessary accessories for endometrial tissue collection, as indicated in the device description and authorization details.

• Is the Monoject Endometrial Sampling Kit sterile and intended for single use?

  While the device data does not explicitly state sterility or single-use status, it is supplied as a kit for endometrial sampling, which in clinical practice typically involves sterile, single-use components to prevent cross-contamination and ensure sample integrity.

• What regulatory pathway was used for the Monoject Endometrial Sampling Kit?

  The device received FDA 510(k) clearance through a traditional submission, demonstrating substantial equivalence to a predicate device under regulation number 884.1175 with product code HHK.