Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TUM-E-VAC

K-Number: K962850 · 1997-02-21

ApplicantEthox Corp.
Decision Date1997-02-21
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TUM-E-VAC is the device name listed in this FDA 510(k) record. The listed applicant is Ethox Corp.. It received FDA 510(k) clearance on 1997-02-21 under 510(k) number K962850. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUM-E-VAC?

TUM-E-VAC is a medical device that received FDA 510(k) clearance on 1997-02-21. The listed applicant is Ethox Corp.. The 510(k) number is K962850.

When did TUM-E-VAC receive FDA 510(k) clearance?

TUM-E-VAC received FDA 510(k) clearance on 1997-02-21, under 510(k) number K962850.

Who is the listed applicant for TUM-E-VAC?

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 TUM-E-VAC?

The FDA product code for TUM-E-VAC is KDH.

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)K935633NO-MESK921946TUM-E-VAC BITE BLOCKK885220PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KITK894927SURGI SQUEEZ

View all 19 devices →

Related Devices (Code: KDH)

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.

K983624GILTECH PLUS CONNECTING TUBE SETGiltech Plus, Inc.K981286SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETSArmm, Inc.K971259COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical ProductsK923497FLUSHING IRRIGATION SETOrion Life Systems, Inc.K920619TRI-MED GASTRIC LAVAGE SYSTEMTri-Med Specialties, 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.

↑