SKIN STAT II SKIN STAPLING MEDICAL DEVICE— 510(k) K844838

Name: FDA 510(k) clearance K844838
Creator: U.S. Food and Drug Administration
Published: 1985-01-23

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K844838 for SKIN STAT II SKIN STAPLING MEDICAL DEVICE, Substantially Equivalent on 1985-01-23. Applicant: Edward Weck, Inc.. Device class: 1.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1984-12-12
Decision date: 1985-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pa, NC, 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 Edward Weck, Inc.

view all

K915378 — WECK TROCAR1992-06-29
K914690 — LM15(TM), CATALOG NUMBER - 5238211992-03-23
K911915 — HEMOCLIP II1992-01-09
K914470 — PNEUMO-SEAL(TM)1991-11-29
K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 1147051991-07-02

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.