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FDA 510(k)

TX1 TISSUE REMOVAL SYSTEM

K-Number: K101561 · 2010-08-27

ApplicantAmerican Optisurgical, Inc.
Decision Date2010-08-27
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

TX1 TISSUE REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Optisurgical, Inc.. It received FDA 510(k) clearance on 2010-08-27 under 510(k) number K101561. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TX1 TISSUE REMOVAL SYSTEM?

TX1 TISSUE REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is American Optisurgical, Inc.. The 510(k) number is K101561.

When did TX1 TISSUE REMOVAL SYSTEM receive FDA 510(k) clearance?

TX1 TISSUE REMOVAL SYSTEM received FDA 510(k) clearance on 2010-08-27, under 510(k) number K101561.

Who is the listed applicant for TX1 TISSUE REMOVAL SYSTEM?

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

What is the FDA product code for TX1 TISSUE REMOVAL SYSTEM?

The FDA product code for TX1 TISSUE REMOVAL SYSTEM is LFL.

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Other records listing American Optisurgical, Inc. 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.

K080803VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551K020527HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030K953538RM001 REUSABLEK953539DM001 DISPOSABLE PACKK952331AOI LC-40 PHACOEMULSIFIER

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

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

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