RE-SHARPENABLE SAW BLADES— 510(k) K940501
Substantially EquivalentAdven Medical
FDA 510(k) clearance K940501 for RE-SHARPENABLE SAW BLADES, Substantially Equivalent on 1994-06-28. Applicant: Adven Medical. Device class: 1.
Clearance details
- Applicant
- Adven Medical
- Product code
- Code GFA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code GFA
view allMore clearances from Adven Medical
view all- K021528 — REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
- K013987 — REPROCESSED DISPOSABLE TROCARS
- K012675 — REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
- K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
- K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
Adverse events under product code GFA
product code GFA- Death
- 2
- Injury
- 140
- Malfunction
- 2,337
- Total
- 2,479
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.