510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964783Substantially Equivalent

Epidural Mini Kit, Eldor Combined Spinal/epidural Kit

Alexander Medical, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964783 is the FDA 510(k) clearance record for EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT, a class II device, cleared for Alexander Medical, Inc. on under FDA product code CAZ (Anesthesia Conduction Kit). FDA's definition for product code CAZ reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list one 510(k) clearance for Alexander Medical, Inc. As of , FDA records show no recalls naming K964783.

Clearance record

Decision date
Received
(77 days to decision)
Product code
CAZ Anesthesia Conduction Kit
Regulation
21 CFR 868.5140
Device class
Class II
Review panel
Anesthesiology
Applicant
Alexander Medical, Inc. 15828 Shady Grove Rd., Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code CAZ

Trailing 12 months
1 clearance under product code CAZ in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260