FDA 510(k)

VALLEYLAB COATED ELECTRODES

K-Number: K950188 · 1995-02-10

Decision Date1995-02-10

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VALLEYLAB COATED ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K950188. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALLEYLAB COATED ELECTRODES?

VALLEYLAB COATED ELECTRODES is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Valleylab, Inc.. The 510(k) number is K950188.

When did VALLEYLAB COATED ELECTRODES receive FDA 510(k) clearance?

VALLEYLAB COATED ELECTRODES received FDA 510(k) clearance on 1995-02-10, under 510(k) number K950188.

Who is the listed applicant for VALLEYLAB COATED ELECTRODES?

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 COATED ELECTRODES?

The FDA product code for VALLEYLAB COATED ELECTRODES is GEI.

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Other records listing Valleylab, Inc. as applicant

K031011LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 K010010VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR K010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE K983743BISURE LAPAROSCOPIC BIPOLAR FORCEPS K981916LIGASURE VESSEL SEALING SYSTEM

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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.