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FDA 510(k)

SURGI-KIT

K-Number: K770590 · 1977-04-14

ApplicantEthox Corp.
Decision Date1977-04-14
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGI-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ethox Corp.. It received FDA 510(k) clearance on 1977-04-14 under 510(k) number K770590. 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 SURGI-KIT?

SURGI-KIT is a medical device that received FDA 510(k) clearance on 1977-04-14. The listed applicant is Ethox Corp.. The 510(k) number is K770590.

When did SURGI-KIT receive FDA 510(k) clearance?

SURGI-KIT received FDA 510(k) clearance on 1977-04-14, under 510(k) number K770590.

Who is the listed applicant for SURGI-KIT?

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

What is the FDA product code for SURGI-KIT?

The FDA product code for SURGI-KIT is KCT.

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Other records listing Ethox 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.

K040286ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFSK031195CUF-COVER (TM)K962850TUM-E-VACK935633NO-MESK921946TUM-E-VAC BITE BLOCKK885220PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT

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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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