Identity
- Trade Name
- Suction and irrigation tube FDA UDI
- Generic Name
- Endoscopic irrigation/aspiration pump FDA UDI
- Model / Reference
- 392 999 202 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082015231 FDA UDI
- 510(k) Number
- K945266 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic irrigation/aspiration pump 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic irrigation/aspiration pump
Suction and irrigation tube by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic irrigation/aspiration pump.
- RocaFlow II - Double Chamber with Aspiration Pump — Promepla · Class II
- RocaFlow II - Simple Chamber — Promepla · Class II
- LAP-Pump — W.O.M. World of Medicine GmbH · Class II
- Endoflow II US – Double Chamber — Promepla · Class II
- Vacuum Protection Gas Filter, hydrophobic — W.O.M. World of Medicine GmbH · Class II
- RocaFlow - Irrigation and Warming System - Single Chamber — Promepla · Class II
- Clarus Endoscopy Pump — CLARUS MEDICAL, LLC · Class II
- OLYMPUS — Keymed (Medical & Industrial Equipment), Ltd. · Class II
Cleared under the same submission
K945266 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Dilation set — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
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
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI b6b6715c-4a61-4e7b-b45e-d076a17775cf 33 fields · synced May 30, 2026