510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K042979Substantially Equivalent

Modification to: Plexalong Sets

Pajunk GmbH Medizintechnologie, Corvallis OR / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042979 is the FDA 510(k) clearance record for MODIFICATION TO: PLEXALONG SETS, a class II device, cleared for Pajunk GmbH on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 63 510(k) clearances for PAJUNK GMBH MEDIZINTECHNOLOGIE, from to . As of , FDA records show no recalls naming K042979.

Clearance record

Decision date
Received
(53 days to decision)
Product code
BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Regulation
21 CFR 868.5150
Device class
Class II
Review panel
Anesthesiology
Applicant
Pajunk GmbH 5010 NW Crescent Valley Dr., Corvallis OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSP

Trailing 12 months

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

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