Identity
- Trade Name
- AURORA Evacuator +Coag FDA UDI
- Generic Name
- General-purpose surgical suction system, vacuum FDA UDI
- Device Name
- The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that combines the ability to aspirate and break up soft tissue and fluids, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site, during minimally invasive surgical procedures. FDA UDI
- Model / Reference
- AEC12F/70 FDA UDI
- Description
- The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that combines the ability to aspirate and break up soft tissue and fluids, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site, during minimally invasive surgical procedures. FDA UDI
Identifiers
- Catalog Number
- AEC12F/70 FDA UDI
- Primary DI / UDI-DI
- 00850002332223 FDA UDI
- 510(k) Number
- K203745 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- General-purpose surgical suction system, vacuum FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 70 Millimeter FDA UDI
Category: Endoscopic electrosurgical electrode, bipolar, single-useGeneral-purpose surgical suction system, vacuum
AURORA Evacuator +Coag by Rebound Therapeutics, Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203745 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
- Rebound Therapeutics, Corporation
Sources (1)
- FDA UDI f7a3f812-da93-4477-bf79-8ee5f08bb3e8 37 fields · synced May 30, 2026