Identity
- Trade Name
- AEON FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Endoscopic Stapler 60mm Reload Purple FDA UDI
- Model / Reference
- AESR60P FDA UDI
- Description
- Endoscopic Stapler 60mm Reload Purple FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851574008080 FDA UDI
- 510(k) Number
- K171589 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
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
Category: Endoscopic manual linear cutting stapler, single-use
Aeon by Lexington Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic manual linear cutting stapler, single-use.
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- Endo GIA Ultra — Covidien LP · Class II
- easyLCTM Linear Cutter Staplers and Loading Units for Single Use — Ezisurg Medical Co., Ltd. · Class II
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd. · 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
Cleared under the same submission
K171589 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
- Lexington Medical, Inc.
Sources (1)
- FDA UDI a0a63792-91c0-45ab-b323-f38fd7806f0e 34 fields · synced May 30, 2026