Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- The product is comprised of a minimally invasive surgical trocar (Outer sheath sleeve, Inner trocar and Optical obturator) and accessories (Lens cleaning syringe and Lens cleaning tube). There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insuf ation and the other attached to the Inner trocar is used for the objective lens cleaning function. The design of the InterLock Trocar maintains the laparoscope and the hand instrument in direct alignment. This feature provides a surgeon with control of the laparoscope image and the hand instrument with one hand, meaning the laparoscope is in direct alignment or parallel to the hand instrument. The hand instrument is always in the eld of view of the laparoscope. The laparoscope does not need to be held by another surgeon or health care personnel. The InterLock Trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparoscope. FDA UDI
- Model / Reference
- DLT05S FDA UDI
- Description
- The product is comprised of a minimally invasive surgical trocar (Outer sheath sleeve, Inner trocar and Optical obturator) and accessories (Lens cleaning syringe and Lens cleaning tube). There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insuf ation and the other attached to the Inner trocar is used for the objective lens cleaning function. The design of the InterLock Trocar maintains the laparoscope and the hand instrument in direct alignment. This feature provides a surgeon with control of the laparoscope image and the hand instrument with one hand, meaning the laparoscope is in direct alignment or parallel to the hand instrument. The hand instrument is always in the eld of view of the laparoscope. The laparoscope does not need to be held by another surgeon or health care personnel. The InterLock Trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparoscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410447866 FDA UDI
- 510(k) Number
- K170084 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Fujifilm by FUJIFILM Corporation — 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
- SECQURE Ultimate — SECQURE SURGICAL, CORP. · Class II
- 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
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
- FUJIFILM Corporation
Sources (1)
- FDA UDI c3f0deba-b0a6-4f05-90f7-efab00224fde 35 fields · synced Jun 8, 2026