SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE— 510(k) K861711

Name: FDA 510(k) clearance K861711
Creator: U.S. Food and Drug Administration
Published: 1986-05-16

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K861711 for SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE, Substantially Equivalent on 1986-05-16. Applicant: Busse Hospital Disposables, Inc.. Device class: 1.

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1986-05-05
Decision date: 1986-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDT

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K963234 — STAPLE REMOVAL KIT1996-10-21
K943719 — VISISTAT STAPLER1994-08-24
K925526 — MANIPLER DISPOSABLE SKIN STAPLER1993-06-24
K915430 — SKIN STAPLE REMOVER KIT1992-02-28
K911204 — QUALTEX SKIN STAPLE EXTRACTOR1991-05-08

More clearances from Busse Hospital Disposables, Inc.

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K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE2012-06-26
K093909 — BUSSE SURGICAL DRAPES IV2010-05-06
K092212 — BUSSE SURGICAL DRAPES III2009-10-09
K082297 — BUSSE SURGICAL DRAPE2008-12-09
K073222 — MODIFICATION TO:SPECIALTY NEEDLES2008-04-09

Adverse events under product code GDT

product code GDT

Malfunction: 752
Total: 752

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.