PBN Hystero-Salpingography Catheter Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K000433 ↗

FDA Product Code

LKF

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• What is the primary function of the PBN Hystero-Salpingography Catheter Set?

  This device is designed to function as a uterine cannula, manipulator, and injector. It is intended to facilitate specific clinical procedures within the field of obstetrics and gynecology.

• Has this device received regulatory authorization?

  Yes, the PBN Hystero-Salpingography Catheter Set has received FDA 510(k) clearance. It is classified under regulation number 884.4530 for use as a uterine cannula, manipulator, and injector.

• Which medical specialty is this device intended for?

  The device is intended for use in the field of obstetrics and gynecology, as indicated by its classification under the OB advisory committee and its design as a uterine instrument.