510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011308Substantially Equivalent

Multistim

Pajunk GmbH Medizintechnologie, Flemington NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011308 is the FDA 510(k) clearance record for MULTISTIM, a class II device, cleared for Pajunk GmbH on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list 63 510(k) clearances for PAJUNK GMBH MEDIZINTECHNOLOGIE, from to . As of , FDA records show no recalls naming K011308.

Clearance record

Decision date
Received
(213 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Pajunk GmbH 203 Main St., Flemington NJ
510(k) summary
Summary
Third party review
No

Clearances, product code BXN

Trailing 12 months

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

FDA records show no clearances under product code BXN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260