CHERRY DISSECTOR— 510(k) K945335

Name: FDA 510(k) clearance K945335
Creator: U.S. Food and Drug Administration
Published: 1994-12-28

Substantially Equivalent

Lorrex Health Products

FDA 510(k) clearance K945335 for CHERRY DISSECTOR, Substantially Equivalent on 1994-12-28. Applicant: Lorrex Health Products. Device class: 1.

Clearance details

Applicant: Lorrex Health Products
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1994-11-01
Decision date: 1994-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Secaucus, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lorrex Health Products

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K945333 — KITTNER DISSECTOR1994-12-28
K945553 — ROUND STICK SPONGES, FLAT STICK SPONGES1994-12-28
K945606 — TRIANGULAR SPONGES1994-12-28
K945866 — CYLINDRICAL SPONGE1994-12-28
K945332 — ROSEBUD DISSECTOR1994-12-05

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.