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FDA 510(k)

CUSA SYSTEM 200 MACRO-DISSECTOR

K-Number: K864983 · 1987-06-23

ApplicantCooper Lasersonics, Inc.
Decision Date1987-06-23
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

CUSA SYSTEM 200 MACRO-DISSECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1987-06-23 under 510(k) number K864983. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSA SYSTEM 200 MACRO-DISSECTOR?

CUSA SYSTEM 200 MACRO-DISSECTOR is a medical device that received FDA 510(k) clearance on 1987-06-23. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K864983.

When did CUSA SYSTEM 200 MACRO-DISSECTOR receive FDA 510(k) clearance?

CUSA SYSTEM 200 MACRO-DISSECTOR received FDA 510(k) clearance on 1987-06-23, under 510(k) number K864983.

Who is the listed applicant for CUSA SYSTEM 200 MACRO-DISSECTOR?

The FDA 510(k) record lists Cooper Lasersonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSA SYSTEM 200 MACRO-DISSECTOR?

The FDA product code for CUSA SYSTEM 200 MACRO-DISSECTOR is LFL.

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Other records listing Cooper Lasersonics, Inc. as applicant

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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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