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FDA 510(k)

SKIN STAPLE REMOVER #523770

K-Number: K801444 · 1980-07-14

ApplicantEdward Weck, Inc.
Decision Date1980-07-14
Product CodeGDT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKIN STAPLE REMOVER #523770 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 1980-07-14 under 510(k) number K801444. The device is classified under product code GDT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN STAPLE REMOVER #523770?

SKIN STAPLE REMOVER #523770 is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Edward Weck, Inc.. The 510(k) number is K801444.

When did SKIN STAPLE REMOVER #523770 receive FDA 510(k) clearance?

SKIN STAPLE REMOVER #523770 received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801444.

Who is the listed applicant for SKIN STAPLE REMOVER #523770?

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 SKIN STAPLE REMOVER #523770?

The FDA product code for SKIN STAPLE REMOVER #523770 is GDT.

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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: GDT)

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.

K963234STAPLE REMOVAL KITContinental Medical Laboratories, Inc.K943719VISISTAT STAPLERPilling Weck, Inc.K925526MANIPLER DISPOSABLE SKIN STAPLERMatsutani Seisakusho Co. , Ltd.K915430SKIN STAPLE REMOVER KITCypress Medical Products, Ltd.K911204QUALTEX SKIN STAPLE EXTRACTORDeroyal Industries, Inc.K910586AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*United States Surgical, A Division of Tyco Healthc

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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