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FDA 510(k)

E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES

K-Number: K921885 · 1994-03-25

ApplicantValleylab, Inc.
Decision Date1994-03-25
Product CodeHGZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

E1070 & E1080 SERIES REUSABLE LLETZ 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 1994-03-25 under 510(k) number K921885. The device is classified under product code HGZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES?

E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Valleylab, Inc.. The 510(k) number is K921885.

When did E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES receive FDA 510(k) clearance?

E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES received FDA 510(k) clearance on 1994-03-25, under 510(k) number K921885.

Who is the listed applicant for E1070 & E1080 SERIES REUSABLE LLETZ 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 E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES?

The FDA product code for E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES is HGZ.

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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