PROPLATE— 510(k) K073360
Substantially EquivalentBio Protech, Inc.
FDA 510(k) clearance K073360 for PROPLATE, Substantially Equivalent on 2007-12-19. Applicant: Bio Protech, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Protech, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
Recent devices under product code GEI
view allMore clearances from Bio Protech, Inc.
view all- K192035 — EvaQMax Smoke Evacuation System
- K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
- K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
- K143103 — PROPENCIL Smoke Pencil
- K142099 — CUTANEOUS ELECTRODES
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . 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.