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FDA 510(k)

DIATEMP ELECTROSURGICAL PEN

K-Number: K853968 · 1985-11-14

ApplicantNdm Corp.
Decision Date1985-11-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIATEMP ELECTROSURGICAL PEN is the device name listed in this FDA 510(k) record. The listed applicant is Ndm Corp.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K853968. 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 DIATEMP ELECTROSURGICAL PEN?

DIATEMP ELECTROSURGICAL PEN is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Ndm Corp.. The 510(k) number is K853968.

When did DIATEMP ELECTROSURGICAL PEN receive FDA 510(k) clearance?

DIATEMP ELECTROSURGICAL PEN received FDA 510(k) clearance on 1985-11-14, under 510(k) number K853968.

Who is the listed applicant for DIATEMP ELECTROSURGICAL PEN?

The FDA 510(k) record lists Ndm Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIATEMP ELECTROSURGICAL PEN?

The FDA product code for DIATEMP ELECTROSURGICAL PEN is GEI.

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Other records listing Ndm Corp. 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.

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Related Devices (Code: GEI)

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

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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