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510(k) K011308

MULTISTIM by Pajunk GmbH — Product Code BXN

K011308 is an FDA 510(k) premarket notification submitted by Pajunk GmbH for the device "MULTISTIM". The FDA issued a decision of Substantially Equivalent on November 29, 2001. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Pajunk GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2001
Date Received
April 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Battery-Powered
Device Class
Class II
Regulation Number
868.2775
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)
  • K042979 — MODIFICATION TO: PLEXALONG SETS (December 21, 2004)
  • 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)

Other clearances for product code BXN

  • K213049 — STIMPOD NMS450 Nerve Stimulator (October 16, 2022)
  • K162086 — MultiStim ECO (January 6, 2017)
  • K153045 — SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator (May 13, 2016)
  • K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator (March 24, 2015)
  • K140853 — STIMPOD ST2-3010 NERVE STIMULATOR (November 6, 2014)
  • K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (March 28, 2013)
  • K111985 — MYOGUIDE SYSTEM MODEL 8008 (December 30, 2011)
  • K110118 — STIMTRODE SINGLE USE NERVE STIMULATOR (February 17, 2011)
  • K102084 — STIMPOD NMS450 NERVE STIMULATOR (December 16, 2010)
  • K093591 — STIMPOD MODEL NMS-400 NERVE STIMULATOR (December 3, 2009)

FDA data resources