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FDA 510(k)

SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS

K-Number: K883091 · 1988-10-14

ApplicantSharplan Lasers, Inc.
Decision Date1988-10-14
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1988-10-14 under 510(k) number K883091. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS?

SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS is a medical device that received FDA 510(k) clearance on 1988-10-14. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K883091.

When did SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS receive FDA 510(k) clearance?

SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS received FDA 510(k) clearance on 1988-10-14, under 510(k) number K883091.

Who is the listed applicant for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS?

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

What is the FDA product code for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS?

The FDA product code for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS is LFL.

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Other records listing Sharplan Lasers, 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.

K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMK971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K971648SHARPLAN ERBIUM: YAG LASER (4020)K971743SHARPLAN CO2 SURGICAL LASER SYSTEMK962446SHARPLAN RUBY LASER SYSTEM

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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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