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FDA 510(k)

VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM

K-Number: K980915 · 1998-06-29

ApplicantValleylab, Inc.
Decision Date1998-06-29
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K980915. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM?

VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Valleylab, Inc.. The 510(k) number is K980915.

When did VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM receive FDA 510(k) clearance?

VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM received FDA 510(k) clearance on 1998-06-29, under 510(k) number K980915.

Who is the listed applicant for VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM?

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 VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM?

The FDA product code for VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM is FYD.

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Other records listing Valleylab, 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.

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: FYD)

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.

K240127PlumeSafe X5 Smoke Management SystemConmed CorporationK2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic CorporationK213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.

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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