Amsel Occluder Device
The Amsel Occluder Device permanently closes blood vessels or other tubular structures during open general surgery. It is used by trained surgeons where a metal ligating clip is indicated…
The Amsel Occluder Device permanently closes blood vessels or other tubular structures during open general surgery. It is used by trained surgeons where a metal ligating clip is indicated and the structure measures 2 to 7 mm in diameter.
A syringe style applicator passes the implant through the target structure. Two compression elements slide together on opposite sides and lock on an implant rod, clamping the structure shut. The applicator then detaches and its needle is withdrawn, leaving the occluder implanted.
Listed Item
The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Implant Materials
The compression elements are made from nitinol and lock with a titanium rod. The device is preloaded, supplied sterile after ethylene oxide processing and intended for one patient and one use.
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 | Amsel Medical Corporation, United States |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K140932 |
| Record published | 2017-05-26 |
| Record revised | 2021-05-19 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Single box, box of 6 of 6, master box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-200 | In distribution |
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 |
| E-Pack | Ethicon, 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 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180650 | 2018-11-15 |
| K172479 | 2017-09-14 |
| K140932 | 2015-01-23 |
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.