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FDA 510(k)

BLADES, SCALPEL CARBON STEET

K-Number: K854860 · 1985-12-24

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

Device Summary

BLADES, SCALPEL CARBON STEET 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 K854860. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLADES, SCALPEL CARBON STEET?

BLADES, SCALPEL CARBON STEET 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 K854860.

When did BLADES, SCALPEL CARBON STEET receive FDA 510(k) clearance?

BLADES, SCALPEL CARBON STEET received FDA 510(k) clearance on 1985-12-24, under 510(k) number K854860.

Who is the listed applicant for BLADES, SCALPEL CARBON STEET?

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 BLADES, SCALPEL CARBON STEET?

The FDA product code for BLADES, SCALPEL CARBON STEET is GES.

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Other records listing Medelec Intl. Corp. as applicant

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Related Devices (Code: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

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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