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FDA 510(k)

SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM

K-Number: K063531 · 2007-02-22

ApplicantSra Developments, Ltd.
Decision Date2007-02-22
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sra Developments, Ltd.. It received FDA 510(k) clearance on 2007-02-22 under 510(k) number K063531. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM?

SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-22. The listed applicant is Sra Developments, Ltd.. The 510(k) number is K063531.

When did SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM receive FDA 510(k) clearance?

SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM received FDA 510(k) clearance on 2007-02-22, under 510(k) number K063531.

Who is the listed applicant for SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM?

The FDA 510(k) record lists Sra Developments, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM?

The FDA product code for SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM is LFL.

Related Clinical Trials

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Other records listing Sra Developments, Ltd. 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.

K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5K072961LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)K032424LOTUS

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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