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FDA 510(k)

TWINTRODE ELC 134 ELECTRODE

K-Number: K012785 · 2001-11-16

ApplicantHealthtronics Surgical Services, Inc.
Decision Date2001-11-16
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TWINTRODE ELC 134 ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Healthtronics Surgical Services, Inc.. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K012785. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWINTRODE ELC 134 ELECTRODE?

TWINTRODE ELC 134 ELECTRODE is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Healthtronics Surgical Services, Inc.. The 510(k) number is K012785.

When did TWINTRODE ELC 134 ELECTRODE receive FDA 510(k) clearance?

TWINTRODE ELC 134 ELECTRODE received FDA 510(k) clearance on 2001-11-16, under 510(k) number K012785.

Who is the listed applicant for TWINTRODE ELC 134 ELECTRODE?

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

What is the FDA product code for TWINTRODE ELC 134 ELECTRODE?

The FDA product code for TWINTRODE ELC 134 ELECTRODE is LNS.

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Other records listing Healthtronics Surgical Services, 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.

K881902HEALTHTRONIC OMEGA TRAC

Related Devices (Code: LNS)

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.

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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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