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FDA 510(k)

DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI

K-Number: K800318 · 1980-03-10

ApplicantEdward Weck, Inc.
Decision Date1980-03-10
Product CodeHBT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1980-03-10 under 510(k) number K800318. The device is classified under product code HBT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI?

DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI is a medical device that received FDA 510(k) clearance on 1980-03-10. The listed applicant is Edward Weck, Inc.. The 510(k) number is K800318.

When did DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI receive FDA 510(k) clearance?

DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI received FDA 510(k) clearance on 1980-03-10, under 510(k) number K800318.

Who is the listed applicant for DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI?

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

What is the FDA product code for DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI?

The FDA product code for DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI is HBT.

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Other records listing Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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Related Devices (Code: HBT)

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.

K924929REFLEX(R) ECARichard-Allan MedicalK896262TITANIUM LIGATING CLIPSRichard-Allan Medical Ind., Inc.K862696TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEPDowns Surgical , Ltd.

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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