510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963570Substantially Equivalent

Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22)

Smiths Industries Medical Systems, Inc., Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963570 is the FDA 510(k) clearance record for SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22), a class II device, cleared for Smiths Industries Medical Systems, Inc. on under FDA product code FMJ (Manometer, Spinal-Fluid). FDA records list 22 510(k) clearances for Smiths Industries Medical Systems, Inc., from to . As of , FDA records show no recalls naming K963570.

Clearance record

Decision date
Received
(43 days to decision)
Product code
FMJ Manometer, Spinal-Fluid
Regulation
21 CFR 880.2500
Device class
Class II
Review panel
General Hospital
Applicant
Smiths Industries Medical Systems, Inc. 15 Kit St., Keene NH
510(k) summary
Summary
Third party review
No

Clearances, product code FMJ

Trailing 12 months

FDA records hold no clearances under product code FMJ in the trailing twelve months.

FDA records show no clearances under product code FMJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMJ, 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 20260
October 20260