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FDA 510(k)

ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM

K-Number: K962525 · 1996-09-19

ApplicantMorwel Corp.
Decision Date1996-09-19
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Morwel Corp.. It received FDA 510(k) clearance on 1996-09-19 under 510(k) number K962525. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM?

ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-19. The listed applicant is Morwel Corp.. The 510(k) number is K962525.

When did ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM receive FDA 510(k) clearance?

ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM received FDA 510(k) clearance on 1996-09-19, under 510(k) number K962525.

Who is the listed applicant for ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM?

The FDA 510(k) record lists Morwel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM?

The FDA product code for ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM is LFL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Morwel Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K841160MORWEL ASPIRATORK841159SUCTION TIPSK831520MORWEL CANNULA

Related Devices (Code: LFL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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