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FDA 510(k)

SKIN STAT II SKIN STAPLING MEDICAL DEVICE

K-Number: K844838 · 1985-01-23

ApplicantEdward Weck, Inc.
Decision Date1985-01-23
Product CodeGDT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKIN STAT II SKIN STAPLING MEDICAL DEVICE 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 1985-01-23 under 510(k) number K844838. 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 STAT II SKIN STAPLING MEDICAL DEVICE?

SKIN STAT II SKIN STAPLING MEDICAL DEVICE is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Edward Weck, Inc.. The 510(k) number is K844838.

When did SKIN STAT II SKIN STAPLING MEDICAL DEVICE receive FDA 510(k) clearance?

SKIN STAT II SKIN STAPLING MEDICAL DEVICE received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844838.

Who is the listed applicant for SKIN STAT II SKIN STAPLING MEDICAL DEVICE?

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 STAT II SKIN STAPLING MEDICAL DEVICE?

The FDA product code for SKIN STAT II SKIN STAPLING MEDICAL DEVICE 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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