H.V. Pulse Lavage (L31 Series)

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

510(k) Number

K970916 ↗

FDA Product Code

FQH

Device Class

Class II

Regulation

21 CFR Part 880.5475

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia Kit

  Class II

  FDA 510(k) K962821 Active Cleared 13 Nov 1996

• Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)

  Class II

  FDA 510(k) K961444 Active Cleared 1 Aug 1996

• Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single Wall Introducer Needle

  Class II

  FDA 510(k) K951448 Active Cleared 27 Mar 1996

• Global Medical Products Brest Lesion Localization Needle with Stiffened Wire

  Class I

  FDA 510(k) K950311 Active Cleared 26 May 1995

• Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene Needles

  Class II

  FDA 510(k) K951421 Active Cleared 16 Nov 1995

• What is the H.V. Pulse Lavage L31 Series used for?

  The H.V. Pulse Lavage L31 Series is a pneumatic surgical instrument designed to irrigate and debride surgical sites. It creates a pulsating action using compressed air or nitrogen to effectively clean surgical areas during procedures.

• How is the H.V. Pulse Lavage L31 Series supplied and is it sterile?

  The device is supplied as a single-use sterile pump set that is inserted into the instrument's cradle. This design isolates sterile fluids from the device itself, ensuring sterility during surgical procedures.

• Is the H.V. Pulse Lavage L31 Series reusable or single-use?

  The H.V. Pulse Lavage L31 Series is designed for single-use with its sterile pump set. The pump set is discarded after each use, while the main instrument can be cleaned and sterilized for future procedures with new pump sets.

• What regulatory approvals does the H.V. Pulse Lavage L31 Series have?

  The H.V. Pulse Lavage L31 Series has FDA 510(k) clearance with product code FQH and is classified as substantially equivalent. It is intended for use in general hospital settings and received clearance on June 20, 1997.