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510(k) K140853

STIMPOD ST2-3010 NERVE STIMULATOR by Xavant Technology (Pty), Ltd. — Product Code BXN

K140853 is an FDA 510(k) premarket notification submitted by Xavant Technology (Pty), Ltd. for the device "STIMPOD ST2-3010 NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on November 6, 2014. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Xavant Technology (Pty), Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2014
Date Received
April 3, 2014
Clearance Type
Special
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 Xavant Technology (Pty), Ltd.

  • K213049 — STIMPOD NMS450 Nerve Stimulator (October 16, 2022)
  • K161091 — STIMPOD NMS460 Nerve Stimulator (January 18, 2017)
  • 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)
  • K072092 — XPOD/XMAP NERVE STIMULATOR (November 15, 2007)

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)
  • 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