ROSEBUD DISSECTOR— 510(k) K953060

Name: FDA 510(k) clearance K953060
Creator: U.S. Food and Drug Administration
Published: 1995-09-14

Substantially Equivalent

Medical Perspectives Corp.

FDA 510(k) clearance K953060 for ROSEBUD DISSECTOR, Substantially Equivalent on 1995-09-14. Applicant: Medical Perspectives Corp.. Device class: 1.

Clearance details

Applicant: Medical Perspectives Corp.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1995-06-30
Decision date: 1995-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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K953057 — CYLINDRICAL SPONGE1995-09-14
K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES1995-09-14
K953059 — KITTNER DISSECTOR1995-09-14
K953062 — CHERRY DISSECTOR1995-09-14
K953087 — CHERRY PIT DISSECTOR1995-09-14

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.