OMNISONICS ULTRASONIC PROBES— 510(k) K993628

Name: FDA 510(k) clearance K993628
Creator: U.S. Food and Drug Administration
Published: 1999-12-15

Substantially Equivalent

Omnisonics Medical Technologies

FDA 510(k) clearance K993628 for OMNISONICS ULTRASONIC PROBES, Substantially Equivalent on 1999-12-15. Applicant: Omnisonics Medical Technologies. Device class: Unclassified.

Clearance details

Applicant: Omnisonics Medical Technologies
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-10-27
Decision date: 1999-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkonton, MA, US

Download summary PDF View on FDA.gov ↗

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K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

More clearances from Omnisonics Medical Technologies

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K083335 — MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM2008-12-15
K071762 — OMNIWAVE ENDOVASCULAR SYSTEM2007-09-27
K052428 — RESOLUTION ENDOVASCULAR SYSTEM2005-12-08
K041705 — RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-22004-09-01
K003824 — OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI2001-03-08

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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 →

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