SX-One MicroKnife— 510(k) K192873

Name: FDA 510(k) clearance K192873
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Sonex Health, Inc.

FDA 510(k) clearance K192873 for SX-One MicroKnife, Substantially Equivalent on 2019-12-20. Applicant: Sonex Health, Inc.. Device class: 1.

Clearance details

Applicant: Sonex Health, Inc.
Product code: Code LXH
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 2019-10-08
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXH

view all

K140414 — IMBIBE NEEDLE2014-04-01
K101609 — SELF RETAINING SOFT TISSUE RETRACTOR2010-12-09
K001507 — MICROPERFORATION INSTRUMENT2000-06-14
K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM1996-01-22
K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY1995-04-26

Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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 K192873

K-number listed on FDA's recall record

Z-1387-2022 — SX-One MicroKnifeClass II·Terminated·SONEX HEALTH LLC·20220629

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192873.

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