Identity
- Trade Name
- TiLink-P Anchor FDA UDI
- Generic Name
- Laparoscopic access cannula anchor, single-use FDA UDI
- Model / Reference
- SI-A-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810131880620 FDA UDI
- 510(k) Number
- K242141 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Laparoscopic access cannula anchor, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laparoscopic access cannula anchor, single-use
TiLink-P Anchor by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic access cannula anchor, single-use.
- Thoracoport — Covidien LP · Class II
- Thoracoport — Covidien LP · Class II
- Thoracoport — Covidien LP · Class II
- EcoBalloon URO — Pajunk GmbH Medizintechnologie · Class II
- Thoracoport — Covidien LP · Class II
- EcoBalloonDuo DIL-BI + URO — Pajunk GmbH Medizintechnologie · Class II
- Thoracoport — Covidien LP · Class II
- Thoracoport — Covidien LP · Class II
Cleared under the same submission
K242141 also covers:
- TiLink-L Implant 30mm x 10mm — SURGENTEC LLC
- TiLink-L Implant 35mm x 10mm — SURGENTEC LLC
- TiLink-L Implant 40mm x 10mm — SURGENTEC LLC
- TiLink-L Implant 45mm x 10mm — SURGENTEC LLC
- TiLink-L Implant 50mm x 10mm — SURGENTEC LLC
- TiLink-L Implant 55mm x 10mm — SURGENTEC LLC
- TiLink-L Implant 60mm x 10mm — SURGENTEC LLC
- TiLink-P Screw 12mm x 25mm — SURGENTEC LLC
- TiLink-P Screw 12mm x 30mm — SURGENTEC LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgentec Llc
Sources (1)
- FDA UDI 3a20b93d-de2b-4291-bf7a-fbbbec2b03fc 33 fields · synced Jun 1, 2026