Identity
- Trade Name
- SECQURE Ultimate FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- Autoshield Trocar, Threaded Cannula, 10mm x 100mm FDA UDI
- Model / Reference
- CQ5560ULT FDA UDI
- Description
- Autoshield Trocar, Threaded Cannula, 10mm x 100mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863634000408 FDA UDI
- 510(k) Number
- K081398 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laparoscopic access cannula, single-use
SECQURE Ultimate by Secqure Surgical, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic access cannula, single-use.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- DR. POYNTER MC — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR.BRIZENDINE LAP CHOLECYSTECTOMY — APPLIED MEDICAL RESOURCES CORP. · Class I
- Secondary trocar with Gas Port + Additional Cannula without Gas Port — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
- Auto-shield trocar, ribbed cannula — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
- BluView — Unimax Medical Systems Inc. · Class II
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- CONZALVO ROBOTIC SLEEVE — APPLIED MEDICAL RESOURCES CORP. · Class II
Cleared under the same submission
K081398 also covers:
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
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
- Secqure Surgical, Corp.
Sources (1)
- FDA UDI 38ab2e90-e571-41f3-a755-70f58add04c8 34 fields · synced May 30, 2026