Echelon
Echelon 3000 60MM Standard
16manufacturers in China registered for this device type
6catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Showing 12 of 16. All 16 manufacturers in China registered for Stapler, Surgical
Record
| Listed by | Ethicon Endo-Surgery, Inc., United States |
|---|---|
| FDA product code | GAG |
| Device type | Stapler, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4740 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2022-09-23 |
| Record revised | 2026-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 80 % RH |
| Packaging | Box of 3, case of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECH45L | In distribution | |
| ECH60S | In distribution | |
| ECH45C | In distribution | |
| ECH60L | In distribution | |
| ECH60C | In distribution | |
| ECH45S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 23 |
| Medline Industries, Inc. | Medline Industries, Inc. | 12 |
| EEA | Covidien LP | 8 |
| DeRoyal | Deroyal Industries, Inc. | 7 |
| Aeon | Lexington Medical, Inc. | 6 |
| easyEndoTM Lite Linear Cutting Stapler for Single Use | Ezisurg Medical Co., Ltd. | 6 |
| Echelon Linear Cutter | Ethicon Endo-Surgery, Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 4 |
| Ethicon | Ethicon Endo-Surgery, Inc. | 3 |
| Tri-Staple 2.0 | Covidien LP | 3 |
| GIA | Covidien LP | 3 |
| Medline | Medline Industries, Inc. | 2 |
Showing 12 of 21. All products under Stapler, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241629 | 2024-07-03 |
| K213633 | 2022-04-08 |
| K970079 | 1997-03-11 |
| K962258 | 1996-09-11 |
| K932476 | 1993-12-01 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-08-12 | Class II | Nonconforming Material/Component | The device may have a non-conforming component that may cause the device to fire an unformed staple. | 42,798 | 2015-07-10 |
| 2012-10-04 | Class II | Package design/selection | Damage to the packaging may have compromised the sterility of the device. | 5,894,975 pieces | 2013-06-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.