Who is the manufacturer of OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI?

Omnisonics Medical Technologies filed the 510(k) submission for OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI (K003824).

What is the FDA product code for OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI?

LFL. as a Class U device in the SU panel.

What is the regulatory pathway for OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI

K003824 · Omnisonics Medical Technologies · LFL · Mar 8, 2001 · SU

Device Facts

Record ID	K003824
Device Name	OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
Applicant	Omnisonics Medical Technologies
Product Code	LFL · SU
Decision Date	Mar 8, 2001
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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