Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia Kit

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

510(k) Number

K962821 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESK Substantially Equivalent — Kit

• H.V. Pulse Lavage (L31 Series)

  Class II

  FDA 510(k) K970916 Active Cleared 20 Jun 1997

• 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