Identity
- Trade Name
- VIKY FDA UDI
- Generic Name
- Laparoscope holder FDA UDI
- Model / Reference
- GX0701 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M975GX07011 FDA UDI
- 510(k) Number
- K082233 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscope holder 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laparoscope holder
Viky by Endocontrol — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscope holder.
- AutoLap Streile Components Kit Package- Clip, 5mm — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
- AutoLap Sterile Components Kit Package- Ring, 10mm — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
- AutoLap Sterile Components Kit Package- Clip, 10mm — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
- AutoLap Single Procedure Kit Pack (Ring, 10mm) — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
- AutoLap Single Procedure Kit Pack (Clip, 10mm) — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
- Clip Command Unit Package — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
- AutoLap PU — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
- Molded Laparoscopic Clippers package- 10mm — M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD · Class II
Cleared under the same submission
K082233 also covers:
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
- Endocontrol
Sources (1)
- FDA UDI 9566f9a0-33b7-4145-8e73-04f3091e34d0 34 fields · synced May 30, 2026