RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT— 510(k) K072736

Name: FDA 510(k) clearance K072736
Creator: U.S. Food and Drug Administration
Published: 2008-01-22

Substantially Equivalent

Rhythmlink International, LLC

FDA 510(k) clearance K072736 for RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT, Substantially Equivalent on 2008-01-22. Applicant: Rhythmlink International, LLC. Device class: 2.

Clearance details

Applicant: Rhythmlink International, LLC
Product code: Code ETN
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 2007-09-27
Decision date: 2008-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K072736

K-number listed on FDA's recall record

Z-1960-2015 — Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.Class II·Terminated·Spine Wave, Inc.·20150504

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072736.

Data sourced from openFDA. This site is unofficial and independent of the FDA.