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FDA 510(k)

LOTUS

K-Number: K032424 · 2003-12-16

ApplicantSra Developments, Ltd.
Decision Date2003-12-16
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

LOTUS 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 2003-12-16 under 510(k) number K032424. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOTUS?

LOTUS is a medical device that received FDA 510(k) clearance on 2003-12-16. The listed applicant is Sra Developments, Ltd.. The 510(k) number is K032424.

When did LOTUS receive FDA 510(k) clearance?

LOTUS received FDA 510(k) clearance on 2003-12-16, under 510(k) number K032424.

Who is the listed applicant for LOTUS?

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 LOTUS?

The FDA product code for LOTUS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)K063531SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM

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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