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FDA 510(k)

THE KEYMED FIBERSCOPE STERILIZATION CASE

K-Number: K860528 · 1986-07-15

ApplicantKeymed, Inc.
Decision Date1986-07-15
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE KEYMED FIBERSCOPE STERILIZATION CASE is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1986-07-15 under 510(k) number K860528. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE KEYMED FIBERSCOPE STERILIZATION CASE?

THE KEYMED FIBERSCOPE STERILIZATION CASE is a medical device that received FDA 510(k) clearance on 1986-07-15. The listed applicant is Keymed, Inc.. The 510(k) number is K860528.

When did THE KEYMED FIBERSCOPE STERILIZATION CASE receive FDA 510(k) clearance?

THE KEYMED FIBERSCOPE STERILIZATION CASE received FDA 510(k) clearance on 1986-07-15, under 510(k) number K860528.

Who is the listed applicant for THE KEYMED FIBERSCOPE STERILIZATION CASE?

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

What is the FDA product code for THE KEYMED FIBERSCOPE STERILIZATION CASE?

The FDA product code for THE KEYMED FIBERSCOPE STERILIZATION CASE is KCT.

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Other records listing Keymed, 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.

K100803OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1K921179OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20K881004OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECRK861821KEYMED FIBERSCOPE AUTO DISINFECTORK864801THE KEYMED HI-LIGHT 250 LIGHT SOURCEK862000KEYMED FLEXIBLE ESOPHAGEAL DILATORS

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Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

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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