FDA 510(k)

POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER

K-Number: K863035 · 1986-09-18

Decision Date1986-09-18

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1986-09-18 under 510(k) number K863035. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER?

POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER is a medical device that received FDA 510(k) clearance on 1986-09-18. The listed applicant is Valleylab, Inc.. The 510(k) number is K863035.

When did POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER receive FDA 510(k) clearance?

POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER received FDA 510(k) clearance on 1986-09-18, under 510(k) number K863035.

Who is the listed applicant for POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER?

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 POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER?

The FDA product code for POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER is GXY.

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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

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