510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042359Substantially Equivalent

Subdural Evacuating Port System Cranial Access Kit (Seps-Ca), (Seps-Cal), (Seps-Cand),models 11-0401 Ca, 11-0401-Cal

Medical Designs, LLC, Sioux Falls SD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042359 is the FDA 510(k) clearance record for SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL, a class II device, cleared for Medical Designs, LLC on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 7 510(k) clearances for Medical Designs, LLC, from to . As of , FDA records show one recall naming K042359.

Clearance record

Decision date
Received
(78 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
Medical Designs, LLC 1210 W. 18th St., Sioux Falls SD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXG

Trailing 12 months
4 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 20260