Identity
- Trade Name
- K-Pump FDA UDI
- Generic Name
- General-purpose surgical suction system, vacuum FDA UDI
- Device Name
- K-Pump Infiltration Device. Surgical Infiltration/ Irrigation pump. Vibration free, quiet K-Pump is capable of infiltration rate from 20-1020 ml/ min. The K-Pump is controlled by pneumatic footswitch. FDA UDI
- Model / Reference
- 1000-0031 FDA UDI
- Description
- K-Pump Infiltration Device. Surgical Infiltration/ Irrigation pump. Vibration free, quiet K-Pump is capable of infiltration rate from 20-1020 ml/ min. The K-Pump is controlled by pneumatic footswitch. FDA UDI
Identifiers
- Catalog Number
- IM-1000-0031 FDA UDI
- Primary DI / UDI-DI
- 00851314007052 FDA UDI
- 510(k) Number
- K991203 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- General-purpose surgical suction system, vacuum FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose surgical suction system, vacuum
K-Pump by Innovative Med, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Innovative Med, Inc.
Sources (1)
- FDA UDI 7cc851f5-9aaf-4dec-b760-9c98be4c049a 36 fields · synced May 30, 2026