SUCTION CATHETER W/STERILE WATER— 510(k) K822510

Name: FDA 510(k) clearance K822510
Creator: U.S. Food and Drug Administration
Published: 1982-10-13

Substantially Equivalent

Medine Dynacor

FDA 510(k) clearance K822510 for SUCTION CATHETER W/STERILE WATER, Substantially Equivalent on 1982-10-13. Applicant: Medine Dynacor. Device class: 1.

Clearance details

Applicant: Medine Dynacor
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1982-08-20
Decision date: 1982-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE2008-12-17
K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN2005-10-21
K043515 — GRAFTSAVER2005-03-31
K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P2002-01-10

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.