E-Pack
12 catalogue numbers from 8500E, listed by Ethicon, Inc., United States, under Clip, Implantable. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
12catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-09-24 |
| Record revised | 2025-07-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 25 °C; Storage environment temperature up to 77 °F; Special storage condition: Away from moisture and direct heat |
| Packaging | Box of 5 |
| Distribution end date | 2019-08-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8500E | Withdrawn | |
| 9824E | Withdrawn | |
| 9827E | Withdrawn | |
| 9815E | Withdrawn | |
| 9875E | Withdrawn | |
| 9878E | Withdrawn | |
| 9699E | Withdrawn | |
| 9832E | Withdrawn | |
| 9316E | Withdrawn | |
| 9817E | Withdrawn | |
| 9809E | Withdrawn | |
| 9831E | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 321 |
| Teleflex | Teleflex Medical LLC | 57 |
| AtriClip™ LAA Exclusion System | Atricure, Inc. | 40 |
| Aesculap | Aesculap AG | 19 |
| Medline | Medline Industries, Inc. | 15 |
| AtriClip Flex•v | Atricure, Inc. | 12 |
| AtriClip® Pro•v™ LAA Exclusion System | Atricure, Inc. | 12 |
| Titanium Ligation Clip | Vesocclude Medical, LLC | 11 |
| SLS-Clip | Vitalitec Surgical | 10 |
| SLS-Clip Vitalitec | Peters Surgical | 10 |
| MirusTM Ligating Clip | Meril Endo Surgery PVT. Ltd. | 10 |
| Clip 9 Vitalitec | Peters Surgical | 10 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K931492 | 1993-08-24 |
| K920847 | 1992-05-29 |
| K864350 | 1986-12-18 |
| K864102 | 1986-11-05 |
| K850273 | 1985-04-17 |
| K834267 | 1984-03-12 |
| K830503 | 1983-03-08 |
| K812323 | 1981-11-16 |
| K811935 | 1981-09-11 |
| K801124 | 1980-06-17 |
| K771413 | 1977-11-28 |
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.