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FDA 510(k)

QUALTEX SKIN STAPLE EXTRACTOR

K-Number: K911204 · 1991-05-08

ApplicantDeroyal Industries, Inc.
Decision Date1991-05-08
Product CodeGDT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALTEX SKIN STAPLE EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1991-05-08 under 510(k) number K911204. 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 QUALTEX SKIN STAPLE EXTRACTOR?

QUALTEX SKIN STAPLE EXTRACTOR is a medical device that received FDA 510(k) clearance on 1991-05-08. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K911204.

When did QUALTEX SKIN STAPLE EXTRACTOR receive FDA 510(k) clearance?

QUALTEX SKIN STAPLE EXTRACTOR received FDA 510(k) clearance on 1991-05-08, under 510(k) number K911204.

Who is the listed applicant for QUALTEX SKIN STAPLE EXTRACTOR?

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

What is the FDA product code for QUALTEX SKIN STAPLE EXTRACTOR?

The FDA product code for QUALTEX SKIN STAPLE EXTRACTOR is GDT.

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Other records listing Deroyal Industries, Inc. as applicant

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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.K910586AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*United States Surgical, A Division of Tyco HealthcK900486APPOSE UNITY STERILE DISPOSABLE SKIN STAPLERDavis & Geck, 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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