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510(k) K143095

MiniStim MS-IVB Peripheral Nerve Stimulator by Halyard Health, Inc. — Product Code BXN

K143095 is an FDA 510(k) premarket notification submitted by Halyard Health, Inc. for the device "MiniStim MS-IVB Peripheral Nerve Stimulator". The FDA issued a decision of Substantially Equivalent on March 24, 2015. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Halyard Health, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2015
Date Received
October 28, 2014
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 Halyard Health, Inc.

  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K180646 — Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy (June 27, 2018)
  • K173955 — Mic-Key* SF Over-the-Wire Stoma Measuring Device (January 26, 2018)
  • K162930 — Aero Chrome* Select Breathable Performance Surgical Gowns (April 21, 2017)
  • K163461 — Coolief* Cooled RF Probe (April 13, 2017)
  • K163236 — COOLIEF Cooled Radiofrequency Kit (December 16, 2016)
  • K161232 — ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Blo (September 30, 2016)
  • K160709 — HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (September 6, 2016)
  • K153255 — Aero Chrome* Breathable Performance Surgical Gown (April 13, 2016)
  • K153708 — Halyard Black-Orange Powder-Free Nitrile Exam Glove (March 31, 2016)

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)
  • 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