Identity
- Trade Name
- Valleylab SM FDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- Smoke Management Extended Nozzle for use with 4" electrode FDA UDI
- Model / Reference
- VSMEN4 FDA UDI
- Description
- Smoke Management Extended Nozzle for use with 4" electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521836372 FDA UDI
- 510(k) Number
- K240572 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Surgical plume evacuation system tube 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 — 4.37 Centimeter FDA UDI
Category: Surgical plume evacuation system tube
Valleylab SM by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical plume evacuation system tube.
- BCL Accessories Kit — CairnSurgical Inc · Class IIb
- Surgimedics® — COASTAL LIFE TECHNOLOGIES, INC. · Class I
- SUSI® — Aesculap AG · Class IIa
- Gynex — GYNEX CORPORATION · Class I
- Buffalo Filter — Conmed Corporation · Class II
- Smoke Tubing — I.C. Medical, Inc. · Class II
- STERILE SURGICAL SCISSORS — Anhui Medfaith Medical Devices Co., Ltd. · Class I
- Bovie — BOVIE MEDICAL CORPORATION · Class II
Cleared under the same submission
K240572 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
- Covidien LP
Sources (1)
- FDA UDI a16827ec-5d48-4a12-888f-7e1e1b31bfef 37 fields · synced May 30, 2026