Identity
- Trade Name
- Ensure(TM) Single-Use Coagulation Forceps FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- The product should be stored in a cool, dry, clean, well-ventilated, non-corrosive gas environment. Do not expose the package to organic solvent, ionizing radiation or ultraviolet radiation. FDA UDI
- Model / Reference
- CF230-B FDA UDI
- Description
- The product should be stored in a cool, dry, clean, well-ventilated, non-corrosive gas environment. Do not expose the package to organic solvent, ionizing radiation or ultraviolet radiation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503548366 FDA UDI
- 510(k) Number
- K202438 FDA UDI
- FDA Product Code
- KGE FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
- Lumen/Inner Diameter — 2.8 Millimeter FDA UDIWidth — 6.3 Millimeter FDA UDILength — 230 Centimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Ensure(TM) Single-Use Coagulation Forceps by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
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- CHOLE KIT 9 — APPLIED MEDICAL RESOURCES CORP. · Class II
Cleared under the same submission
K202438 also covers:
- Ensure(TM) Single-Use Coagulation Forceps — Micro-Tech (Nanjing) Co., Ltd.
- Ensure(TM) Single-Use Coagulation Forceps — Micro-Tech (Nanjing) Co., Ltd.
- Ensure(TM) Single-Use Coagulation Forceps — Micro-Tech (Nanjing) Co., Ltd.
- Ensure(TM) Single-Use Coagulation Forceps — Micro-Tech (Nanjing) Co., Ltd.
- Ensure(TM) Single-Use Coagulation Forceps — Micro-Tech (Nanjing) Co., Ltd.
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
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA UDI 2ee0c87e-50f1-47e4-aba6-9c4143af625e 36 fields · synced Jun 8, 2026