Dex-Cell Hysteroscopy Fluid Delivery Device

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K892001 ↗

FDA Product Code

HIG

Device Class

Class II

Regulation

21 CFR Part 884.1700

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Dexide, Inc. →

• What is the DEX-CELL hysteroscopy fluid delivery device used for?

  The DEX-CELL hysteroscopy fluid delivery device is an insufflator used for fluid delivery during hysteroscopy procedures, as it is classified under FDA regulation number 884.1700 for hysteroscopic insufflators intended to distend the uterine cavity with fluid for visualization.

• How is the DEX-CELL hysteroscopy fluid delivery device supplied?

  The DEX-CELL hysteroscopy fluid delivery device is supplied as a reusable or single-use system depending on configuration, allowing flexibility for clinical settings based on infection control protocols and facility preferences for reprocessing or disposal.

• What regulatory pathway was used for the DEX-CELL hysteroscopy fluid delivery device?

  The DEX-CELL hysteroscopy fluid delivery device received FDA 510(k) clearance (K892001) on June 16, 1989, through a traditional submission demonstrating substantial equivalence to a legally marketed predicate device under Class II regulations for hysteroscopic insufflators.