Apple Medical One-Touch Uterine Sampler

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K000026 ↗

FDA Product Code

HHK

Device Class

Class II

Regulation

21 CFR Part 884.1175

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Apple Medical Ob Mobius Elastic Retractor

  Class II

  FDA 510(k) K041131 Active Cleared 13 May 2004

• Lweet Cone Biopsy Instrument

  Class II

  FDA 510(k) K961460 Active Cleared 19 Nov 1996

• Apple Medical Mobius Elastic Retractor

  Class II

  FDA 510(k) K014005 Active Cleared 15 Feb 2002

• Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158 Open recall

  Class II

  FDA 510(k) K061651 Active Cleared 20 Oct 2006

• Apple Medical/Ob Mobius Elastic Retractor

  Class I

  FDA 510(k) K050256 Active Cleared 26 Apr 2005

• The Assistant

  Class I

  FDA 510(k) K952841 Active Cleared 18 Aug 1995

See all devices from Apple Medical Corp. →

• What is the Apple Medical One-Touch Uterine Sampler used for?

  The Apple Medical One-Touch Uterine Sampler is an endometrial suction curette designed to collect tissue samples from the uterus and endometrial lining. It combines scraping and vacuum suction to facilitate diagnostic procedures such as endometrial biopsy or uterine cavity assessment, commonly used in obstetrics and gynecology settings.

• Is the Apple Medical One-Touch Uterine Sampler single-use or reusable?

  The Apple Medical One-Touch Uterine Sampler is supplied as a single-use instrument. This design eliminates the need for sterilization between procedures, reducing the risk of cross-contamination and ensuring compliance with aseptic protocols for diagnostic tools.

• How should the Apple Medical One-Touch Uterine Sampler be stored?

  The device should be stored following standard aseptic protocols for single-use diagnostic instruments. Proper storage ensures its integrity and safety for clinical use, adhering to regulatory and clinical safety standards.

• What regulatory pathway does the Apple Medical One-Touch Uterine Sampler follow?

  The Apple Medical One-Touch Uterine Sampler is regulated under 21 CFR 884.1175 and holds an FDA 510(k) clearance (K000026) with a decision of Substantially Equivalent (SESE). It is categorized under product code HHK for endometrial curettes, suction type, and is intended for in-clinic diagnostic applications only.

• Can the Apple Medical One-Touch Uterine Sampler be used outside of a clinical setting?

  No, the Apple Medical One-Touch Uterine Sampler is specifically designed for in-clinic diagnostic use only. Its application is limited to controlled environments where endometrial tissue sampling can be performed safely and effectively under medical supervision.