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FDA 510(k)

CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS

K-Number: K934628 · 1995-07-11

ApplicantValleylab, Inc.
Decision Date1995-07-11
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K934628. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS?

CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Valleylab, Inc.. The 510(k) number is K934628.

When did CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS receive FDA 510(k) clearance?

CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS received FDA 510(k) clearance on 1995-07-11, under 510(k) number K934628.

Who is the listed applicant for CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS?

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

What is the FDA product code for CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS?

The FDA product code for CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS is LFL.

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Other records listing Valleylab, Inc. as applicant

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K031011LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500K010010VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATORK010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEK983743BISURE LAPAROSCOPIC BIPOLAR FORCEPSK981916LIGASURE VESSEL SEALING 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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