easyLCTM Linear Cutter Staplers and Loading Units for Single Use
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- easyLCTM Linear Cutter Staplers and Loading Units for Single Use FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Linear Cutter Staplers, 80±2mm Length, Blue FDA UDI
- Model / Reference
- LCE80 FDA UDI
- Description
- Linear Cutter Staplers, 80±2mm Length, Blue FDA UDI
Identifiers
- Catalog Number
- LCE80 FDA UDI
- Primary DI / UDI-DI
- 06925776119289 FDA UDI
- 510(k) Number
- K181657 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Endoscopic manual linear cutting stapler, single-use
The easyLCTM Linear Cutter Staplers and Loading Units for Single Use are a compact, single-use surgical instrument designed for laparoscopic and open-endoscopic procedures. These instruments feature a manual linear cutting mechanism that eliminates the need for temporary clamping, allowing for faster and more efficient tissue manipulation.
Similar devices
Also classified as Endoscopic manual linear cutting stapler, single-use.
- ECHELON ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
- Endo GIA Ultra — Covidien LP · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Titan SGS Standard Gastric Stapler — Standard Bariatrics · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Cleared under the same submission
K181657 also covers:
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyLCTM Linear Cutter Staplers and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyLCTM Linear Cutter Staplers and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyLCTM Linear Cutter Staplers and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Ezisurg Medical Co., Ltd.
Sources (1)
- FDA UDI 7a86c69b-bb9c-44aa-a953-1d6c4d9c4f8d 36 fields · synced Jul 16, 2026