510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170305Substantially Equivalent

Spinal Manometer NRFit; Spinal Manometer LUER

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

K170305 is the FDA 510(k) clearance record for Spinal Manometer NRFit; Spinal Manometer LUER, a class II device, cleared for PAJUNK GmbH Medizintechnologie on under FDA product code FMJ (Manometer, Spinal-Fluid). FDA records list 63 510(k) clearances for PAJUNK GmbH Medizintechnologie, from to . As of , FDA records show no recalls naming K170305.

Clearance record

Decision date
Received
(175 days to decision)
Product code
FMJ Manometer, Spinal-Fluid
Regulation
21 CFR 880.2500
Device class
Class II
Review panel
General Hospital
Applicant
PAJUNK GmbH Medizintechnologie Karl-Hall-Str 1, Geisingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMJ

Trailing 12 months

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

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