510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K033018Substantially Equivalent

Stimulong Plus Catheter Set Model, Various

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

K033018 is the FDA 510(k) clearance record for STIMULONG PLUS CATHETER SET MODEL, VARIOUS, a class II device, cleared for Pajunk GmbH on under FDA product code CAZ (Anesthesia Conduction Kit). FDA's definition for product code CAZ reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list 63 510(k) clearances for PAJUNK GMBH MEDIZINTECHNOLOGIE, from to . As of , FDA records show no recalls naming K033018.

Clearance record

Decision date
Received
(222 days to decision)
Product code
CAZ Anesthesia Conduction Kit
Regulation
21 CFR 868.5140
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 CAZ

Trailing 12 months
1 clearance under product code CAZ in the twelve months to November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260