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FDA 510(k)

SCALPEL HANDLE

K-Number: K854858 · 1985-12-24

ApplicantMedelec Intl. Corp.
Decision Date1985-12-24
Product CodeGDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCALPEL HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Medelec Intl. Corp.. It received FDA 510(k) clearance on 1985-12-24 under 510(k) number K854858. The device is classified under product code GDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCALPEL HANDLE?

SCALPEL HANDLE is a medical device that received FDA 510(k) clearance on 1985-12-24. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K854858.

When did SCALPEL HANDLE receive FDA 510(k) clearance?

SCALPEL HANDLE received FDA 510(k) clearance on 1985-12-24, under 510(k) number K854858.

Who is the listed applicant for SCALPEL HANDLE?

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

What is the FDA product code for SCALPEL HANDLE?

The FDA product code for SCALPEL HANDLE is GDZ.

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Other records listing Medelec Intl. 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.

K961013DISPOSABLE NEEDLE ELECTRODEK935017TD50 ELECTROMYOGRAPHK922548MEDELEC 2110 AND 2114 EEGK920127ELECTROENCEPHALOGRAPH RECORDING SYSTEMK912775SAPPHIRE 4ME EMG/EP SYSTEMK865106PROPHYLACTIC (CONDOM) MR. JOHNNY

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Related Devices (Code: GDZ)

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.

K091462SPECTRA MEDICAL SAFETY SCAPELSpectra, Inc.K890242SCALPEL HANDLEKinetic Medical ProductsK884512BEAVER(R) HANDLEBd Becton Dickinson Vacutainer Systems PreanalyticK863951P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLEPrecision Surgical Industries, Inc.K863808THE S. CORDERO STYLUSS. Cordero Co.K863212KEISEI HANDLES FOR SURGICAL BLADESKeisei Medical Industrial Co., Ltd.

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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