Identity
- Trade Name
- GI Genius FDA UDI
- Generic Name
- Endoscopic video image interpretive unit FDA UDI
- Device Name
- GGI Genius (TM) System 200 FDA UDI
- Model / Reference
- GGS200 FDA UDI
- Description
- GGI Genius (TM) System 200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521844544 FDA UDI
- 510(k) Number
- K231143 FDA UDI
- FDA Product Code
- QNP FDA UDI
- GMDN Term
- Endoscopic video image interpretive unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1520 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
Yes
FDA UDI
Category: Endoscopic video image interpretive unit
GI Genius by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image interpretive unit.
- SKOUT system — Iterative Scopes, Inc. · Class II
- GI Genius™ Module 300 — LINKVERSE SRL · Class II
- GI Genius™ Module 200 — LINKVERSE SRL · Class II
- GI Genius™ Module 100 — LINKVERSE SRL · Class II
- MAGENTIQ-COLO (ME-APDS) — MAGENTIQ EYE LTD · Class II
- SKOUT system — Iterative Scopes, Inc. · Class II
- GI Genius — Covidien LP · Class II
- GI Genius — Covidien LP · Class II
Cleared under the same submission
K231143 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
- Covidien LP
Sources (1)
- FDA UDI d83c63a3-f1b9-4f25-8bc8-2a75da402339 37 fields · synced Jun 8, 2026