Identity
- Trade Name
- ENDO SMARTCAP FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, reusable FDA UDI
- Device Name
- ENDO SMARTCAP Adapter FDA UDI
- Model / Reference
- 100555 FDA UDI
- Description
- ENDO SMARTCAP Adapter FDA UDI
Identifiers
- Catalog Number
- 100555 FDA UDI
- Primary DI / UDI-DI
- 00677964057328 FDA UDI
- 510(k) Number
- K093665 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, reusable 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
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
Category: Endoscopic insufflation tubing set, reusable
Endo Smartcap by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic insufflation tubing set, reusable.
- Insufflation tube — Guangdong Optomedic Technologies, Inc. · Class II
- MEDICAL GAS PIPELINE ADAPTOR (DISS) FOR UHI-3 — Olympus Medical Systems Corporation · Class II
- CO2 Source Tubing Adapter Olympus UCR — Micro-tech Usa · Class I
- Protego Hybrid Tubing — GA Health Company Limited · Class II
- CYLINDER HOSE — Olympus Medical Systems Corporation · Class II
- LOW FLOW GAS TUBE — Olympus Medical Systems Corporation · Class II
- CO2 Source Tubing Adapter (Non-Sterile) — GA Health Company Limited · Class I
- Hydra — Boston Scientific · Class II
Cleared under the same submission
K093665 also covers:
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
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 |
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Manufacturer
- Manufacturer
- Medivators Inc.
Sources (1)
- FDA UDI 5955b5d1-702f-4192-89cb-262933651ad4 36 fields · synced Jun 8, 2026