B-D Spinal Anesthesia Tray Spinal

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K953467 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K854093 Active Cleared 12 Nov 1985

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• What is the B-D Spinal Anesthesia Tray used for?

  The B-D Spinal Anesthesia Tray is an anesthesia conduction kit used for spinal anesthesia procedures. It contains the components necessary to conduct spinal anesthesia, such as spinal needles and associated supplies, but does not include drug ampoules, which must be supplied separately.

• Is the B-D Spinal Anesthesia Tray sterile or non-sterile, and is it reusable?

  The B-D Spinal Anesthesia Tray is supplied as a non-sterile, reusable tray intended for use in clinical settings. It must be cleaned and sterilized by the user before each use, as it is not provided in a sterile condition.

• What regulatory clearance does the B-D Spinal Anesthesia Tray have?

  The device received FDA 510(k) clearance under K953467 and is classified as a Class II medical device under regulation number 868.5140, with a product code of CAZ and an advisory committee classification in Anesthesiology.