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FDA 510(k)

CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES

K-Number: K882469 · 1988-12-01

ApplicantOrthoconcept, Inc.
Decision Date1988-12-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES is the device name listed in this FDA 510(k) record. The listed applicant is Orthoconcept, Inc.. It received FDA 510(k) clearance on 1988-12-01 under 510(k) number K882469. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES?

CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES is a medical device that received FDA 510(k) clearance on 1988-12-01. The listed applicant is Orthoconcept, Inc.. The 510(k) number is K882469.

When did CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES receive FDA 510(k) clearance?

CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES received FDA 510(k) clearance on 1988-12-01, under 510(k) number K882469.

Who is the listed applicant for CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES?

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

What is the FDA product code for CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES?

The FDA product code for CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES is HRX.

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Other records listing Orthoconcept, 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.

K925160ARTHRO FMS 4K910164ORTHOCONCEPT ARTHROSCOPIC PUMPK905785ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)K896196ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHARK895643MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEMK894363UROPUMP* FLUID MANAGEMENT SYSTEM

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Related Devices (Code: HRX)

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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