Identity
- Trade Name
- PENADAPT EUDAMEDFDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- Electrosurgical Accessories EUDAMEDPenAdapt (Cut-Back) Electrosurgical Pencil Adapter 10 ft (30.5 m) tubing FDA UDIPenAdapt Electrosurgical Pencil Adapter 10 ft (3.05 m) tubing FDA UDI
- Model / Reference
- PA2010 EUDAMEDFDA UDIPA2010CB FDA UDI
- Description
- PenAdapt (Cut-Back) Electrosurgical Pencil Adapter 10 ft (30.5 m) tubing FDA UDIPenAdapt Electrosurgical Pencil Adapter 10 ft (3.05 m) tubing FDA UDI
Identifiers
- Catalog Number
- PA2010CB FDA UDIPA2010 FDA UDI
- Primary DI / UDI-DI
- 20845854080778 EUDAMEDFDA UDI20845854080808 FDA UDI
- Basic UDI-DI
- B-20845854080778 EUDAMED
- 510(k) Number
- K230547 FDA UDI
- FDA Product Code
- FYD FDA UDI
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Surgical plume evacuation system tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Radiation Sterilization FDA UDI
Category: Surgical plume evacuation system tube
Penadapt by Conmed Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical plume evacuation system tube.
- Valleylab — Covidien LP · Class II
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- Surgimedics® — COASTAL LIFE TECHNOLOGIES, INC. · Class I
- SUSI® — Aesculap AG · Class IIa
- Gynex — GYNEX CORPORATION · Class I
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (3)
- FDA UDI c801bd78-a6de-41ef-bfb3-2311ae571d2c 35 fields · synced Jul 22, 2026
- FDA UDI e7c25dd9-cceb-44a0-949d-4f39e299a2e8 36 fields · synced May 30, 2026
- EUDAMED 3b91124c-6362-41ac-bcd6-840351ae212f 61 fields · synced Jul 22, 2026