Identity
- Trade Name
- Heli-FX™ EndoAnchor™ System FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
- Device Name
- ACC EC-05 ANCIL ENDOANCHOR CASSETTE US FDA UDI
- Model / Reference
- EC-05 FDA UDI
- Description
- ACC EC-05 ANCIL ENDOANCHOR CASSETTE US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000225957 FDA UDI
- 510(k) Number
- K171427 FDA UDI
- FDA Product Code
- OTD FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Soft-tissue/mesh anchor, non-bioabsorbable
Heli-FX™ EndoAnchor™ System by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue/mesh anchor, non-bioabsorbable.
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- MectaFix CL Fixation Button with Continuous Loop — Medacta International · Class II
- HNM MEDICAL — HNM STAINLESS, LLC. · Class II
- MectaLock PEEK Suture Anchor — Medacta International · Class II
- MectaScrew PEEK — Medacta International · Class II
- Anchorsure — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
- FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class II
- Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC. · Class II
Cleared under the same submission
K171427 also covers:
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 3a140f26-77c5-4ff7-b913-df492ac851e8 36 fields · synced Jun 1, 2026