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FDA 510(k)

SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE

K-Number: K861711 · 1986-05-16

ApplicantBusse Hospital Disposables, Inc.
Decision Date1986-05-16
Product CodeGDT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 1986-05-16 under 510(k) number K861711. 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 WITH SPONGE STERILE DISPOSABLE?

SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K861711.

When did SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE receive FDA 510(k) clearance?

SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861711.

Who is the listed applicant for SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE?

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

What is the FDA product code for SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE?

The FDA product code for SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE is GDT.

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Other records listing Busse Hospital Disposables, 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.

K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLEK093909BUSSE SURGICAL DRAPES IVK092212BUSSE SURGICAL DRAPES IIIK082297BUSSE SURGICAL DRAPEK073222MODIFICATION TO:SPECIALTY NEEDLESK070465BUSSE EPIDURAL CATHETER

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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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