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510(k) K162086

MultiStim ECO by PAJUNK GmbH Medizintechnologie — Product Code BXN

K162086 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "MultiStim ECO". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2017
Date Received
July 27, 2016
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 Medizintechnologie

  • K243690 — SonoMSK (July 1, 2025)
  • K243682 — SonoPlex STIM; SonoPlex II (June 27, 2025)
  • K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (June 25, 2025)
  • K243525 — SonoTAP and SonoTAP II (March 24, 2025)
  • K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (November 22, 2024)
  • K241954 — SonoBlock; SonoBlock II (September 11, 2024)
  • K230701 — Stim2Go (November 24, 2023)
  • K230201 — Disposable Pre-calibrated Brain Biopsy Needle 2.0 (February 22, 2023)
  • K220897 — Disposable Brain Biopsy Needle 2.0 (August 17, 2022)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)

Other clearances for product code BXN

  • K213049 — STIMPOD NMS450 Nerve Stimulator (October 16, 2022)
  • 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)
  • K091155 — ASCEND (September 3, 2009)

FDA data resources