APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER— 510(k) K900486

Name: FDA 510(k) clearance K900486
Creator: U.S. Food and Drug Administration
Published: 1990-04-20

Substantially Equivalent

Davis & Geck, Inc.

FDA 510(k) clearance K900486 for APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER, Substantially Equivalent on 1990-04-20. Applicant: Davis & Geck, Inc.. Device class: 1.

Clearance details

Applicant: Davis & Geck, Inc.
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1990-02-01
Decision date: 1990-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDT

view all

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 Davis & Geck, Inc.

view all

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.