Identity
- Trade Name
- COMEG MEDICAL FDA UDI
- Generic Name
- Laparoscopic insufflator FDA UDI
- Device Name
- This device is designed to create pneumoperitoneum (distension of the abdomen with CO2 gas) as part of a diagnostic and/or operative laparoscopy procedure. FDA UDI
- Model / Reference
- INSUFF SOPRO 45L PACK 1 US FDA UDI
- Description
- This device is designed to create pneumoperitoneum (distension of the abdomen with CO2 gas) as part of a diagnostic and/or operative laparoscopy procedure. FDA UDI
Identifiers
- Catalog Number
- S_640_4005 FDA UDI
- Primary DI / UDI-DI
- M430S64040051 FDA UDI
- 510(k) Number
- K070783 FDA UDI
- FDA Product Code
- HIF FDA UDI
- GMDN Term
- Laparoscopic insufflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1730 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: Laparoscopic insufflator
Comeg Medical by Sopro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic insufflator.
- Insufflator — Guangdong Optomedic Technologies, Inc. · Class II
- Hose for CO2 central gas supply AGA:US, 5 m — W.O.M. World of Medicine GmbH · Class I
- Synergy Insufflation — W.O.M. World of Medicine GmbH · Class II
- High pressure tube CO2 DIN:US — W.O.M. World of Medicine GmbH · Class I
- CO2 gas connecter, angled — W.O.M. World of Medicine GmbH · Class I
- Switch valve for insufflators — W.O.M. World of Medicine GmbH · Class I
- Hose for CO2 central gas UNI:US, 5m — W.O.M. World of Medicine GmbH · Class I
- HIGHFLOW — Richard Wolf GmbH · Class II
Cleared under the same submission
K070783 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 |
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Manufacturer
- Manufacturer
- Sopro
Sources (1)
- FDA UDI c6db784e-538c-4f5b-ab55-024bd80672dd 36 fields · synced May 30, 2026