SKIN STAPLING DEVICE SC2000— 510(k) K832709

Name: FDA 510(k) clearance K832709
Creator: U.S. Food and Drug Administration
Published: 1983-09-26

Substantially Equivalent

Prosper, Inc.

FDA 510(k) clearance K832709 for SKIN STAPLING DEVICE SC2000, Substantially Equivalent on 1983-09-26. Applicant: Prosper, Inc.. Device class: 1.

Clearance details

Applicant: Prosper, Inc.
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1983-08-12
Decision date: 1983-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, US

Download summary PDF View on FDA.gov ↗

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K925526 — MANIPLER DISPOSABLE SKIN STAPLER1993-06-24
K915430 — SKIN STAPLE REMOVER KIT1992-02-28
K911204 — QUALTEX SKIN STAPLE EXTRACTOR1991-05-08

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K833085 — STAPLE REMOVER SR300P1984-12-14

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.