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510(k) K042979

MODIFICATION TO: PLEXALONG SETS by Pajunk GmbH — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2004
Date Received
October 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

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)
  • K053283 — UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET (January 12, 2006)
  • K053282 — ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP (December 13, 2005)
  • K043130 — MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER 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)

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  • K243525 — SonoTAP and SonoTAP II (March 24, 2025)
  • K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (November 22, 2024)
  • K241954 — SonoBlock; SonoBlock II (September 11, 2024)
  • K240253 — Reach Needle (March 21, 2024)
  • K212982 — Medispine - Spinal Needle, Glospine - Spinal Needle (July 29, 2022)
  • K211085 — BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (July 1, 2022)
  • K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (December 22, 2021)