Home / 510(k) Clearances / K053283

510(k) K053283

UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET by Pajunk GmbH — Product Code CAZ

K053283 is an FDA 510(k) premarket notification submitted by Pajunk GmbH for the device "UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET". The FDA issued a decision of Substantially Equivalent on January 12, 2006. The device falls under product code CAZ (Anesthesia Conduction Kit), a Class II device regulated under 21 CFR 868.5140. Pajunk GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2006
Date Received
November 25, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anesthesia Conduction Kit
Device Class
Class II
Regulation Number
868.5140
Review Panel
AN
Submission Type

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 guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Pajunk GmbH

  • K113207 — SONO TAP, TUOHY SONO (February 29, 2012)
  • K113209 — CHIBA SONO (November 21, 2011)
  • K060563 — EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV (June 2, 2006)
  • K053282 — ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP (December 13, 2005)
  • K043130 — MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS (December 21, 2004)
  • K042979 — MODIFICATION TO: PLEXALONG SETS (December 21, 2004)
  • K040965 — PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (September 7, 2004)
  • K033018 — STIMULONG PLUS CATHETER SET MODEL, VARIOUS (May 5, 2004)
  • K033249 — PAJUNK MODULAR HANDLE INSTRUMENTS (March 5, 2004)
  • K023218 — MODIFICATION TO PLEXOLONG SETS (March 24, 2003)

Other clearances for product code CAZ

  • K222341 — Arrow 0.2 Micron Flat Filter, GVS (February 13, 2023)
  • K210983 — BD Epilor Syringe (May 19, 2022)
  • K201356 — Plastic LOR Syringe (February 12, 2021)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)
  • K190345 — VPC (May 16, 2019)
  • K161075 — Arrow Epidural Catheter Kit (October 4, 2016)
  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K143581 — Arrow Epidural Catheter Kit (June 26, 2015)
  • K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (December 21, 2012)
  • K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN (September 14, 2012)

FDA data resources