CENTURION SKIN STAPLE REMOVER— 510(k) K822365

Name: FDA 510(k) clearance K822365
Creator: U.S. Food and Drug Administration
Published: 1982-08-27

Substantially Equivalent

Tri-State

FDA 510(k) clearance K822365 for CENTURION SKIN STAPLE REMOVER, Substantially Equivalent on 1982-08-27. Applicant: Tri-State. Device class: 1.

Clearance details

Applicant: Tri-State
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1982-08-06
Decision date: 1982-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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

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.