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510(k) K860126

STIMUPLEX, NERVE STIMULATOR by Burron Medical Products, Inc. — Product Code BXN

K860126 is an FDA 510(k) premarket notification submitted by Burron Medical Products, Inc. for the device "STIMUPLEX, NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on February 28, 1986. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Burron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1986
Date Received
January 14, 1986
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 Burron Medical Products, Inc.

  • K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (May 1, 1987)
  • K862412 — INTESTOPLANT (November 13, 1986)
  • K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT (July 1, 1986)
  • K851293 — IMPLANTOFIX (January 9, 1986)
  • K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING (July 9, 1984)
  • K834299 — LONG TERM CENTRAL VENOUS ACCESS CATH (May 1, 1984)
  • K834383 — DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT (May 1, 1984)
  • K834473 — MULTI-LUMEN CENTRAL VENOUS CATH. KIT (April 30, 1984)
  • K840179 — CONTINUOUS EPIDURAL ANESTHES. TRAY (February 24, 1984)
  • K840287 — BRACHIAL PLEXUS ANESTHESIA TRAY (February 23, 1984)

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