510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K021196Substantially Equivalent

Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model Pn1000735

Neuron Therapeutics, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021196 is the FDA 510(k) clearance record for NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735, a class II device, cleared for Neuron Therapeutics, Inc. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list one 510(k) clearance for Neuron Therapeutics, Inc. As of , FDA records show no recalls naming K021196.

Clearance record

Decision date
Received
(76 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Neuron Therapeutics, Inc. 81 Great Valley Pkwy., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXG

Trailing 12 months
5 clearances under product code JXG in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261