TIGERPAW SYSTEM II— 510(k) K111064
Substantially EquivalentLaax, Inc.
FDA 510(k) clearance K111064 for TIGERPAW SYSTEM II, Substantially Equivalent on 2011-05-18. Applicant: Laax, Inc.. Device class: 2.
Clearance details
- Applicant
- Laax, Inc.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Orinda, CA, US
Recent devices under product code GDW
view allMore clearances from Laax, Inc.
view allAdverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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 →
Recalls naming K111064
K-number listed on FDA's recall record- Z-1461-2015 — TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
- Z-1462-2015 — TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111064.
Data sourced from openFDA. This site is unofficial and independent of the FDA.