NEOTRACT ANCHOR SYSTEM MODEL TAS400— 510(k) K102028
Substantially EquivalentNeotract, Inc.
FDA 510(k) clearance K102028 for NEOTRACT ANCHOR SYSTEM MODEL TAS400, Substantially Equivalent on 2010-08-04. Applicant: Neotract, Inc.. Device class: 2.
Clearance details
- Applicant
- Neotract, Inc.
- Product code
- Code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code GAT
view allMore clearances from Neotract, Inc.
view all- K232558 — UroLift 2 ATC Advanced Tissue Control System
- K212396 — UroLift System Rigid Retrieval Kit Sterilization Tray
- K201837 — UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
- K200441 — UroLift Advanced Tissue Control (ATC) System
- K192781 — UroLift System Procedure Kit Sterilization Tray
Adverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
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.