N1101 Nexus Ligator 5 Pack
The Nexus hemorrhoid ligator is a handheld instrument for rubber-band ligation of hemorrhoids. Trained medical personnel use it in hospitals, clinics and doctors’ offices to place a band…
The Nexus hemorrhoid ligator is a handheld instrument for rubber-band ligation of hemorrhoids. Trained medical personnel use it in hospitals, clinics and doctors’ offices to place a band around the hemorrhoid base and cut off its blood supply.
An internal suction source holds the hemorrhoidal tissue while the instrument slips a ligation band around it. The disposable ligator is supplied with preloaded non-latex rubber bands and is intended for single use. The listed N1101 package contains five ligators.
Listed Item
The inx Medical Nexus Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The inx Medical Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.
Use Restrictions
It is not intended for anal polyps, Grade IV hemorrhoids, perineal infection, perineal Crohn’s disease or portal hypertension. Treatment of patients taking anticoagulants such as warfarin requires caution.
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (2), Beijing (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Tongchuang Medical Instrument Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Inx Medical, United States |
|---|---|
| FDA product code | FHN |
| Device type | Ligator, Hemorrhoidal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| 510(k) | K131282 |
| Record published | 2019-11-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N1101-5 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 20 |
| Hemorrhoids Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 16 |
| Millennium | Avalign Technologies, Inc. | 15 |
| Hayden Medical | Hayden Medical Inc | 12 |
| Ligation Device | LEO Medical Co., Ltd. | 12 |
| BR Surgical, LLC | BR Surgical LLC | 11 |
| ESI | FTT Medical, Inc. | 11 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Surtex | Surtex Instruments Ltd | 8 |
| Aesculap | Aesculap AG | 8 |
| Avalign | Avalign Technologies, Inc. | 8 |
Showing 12 of 64. All products under Ligator, Hemorrhoidal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131282 | 2013-07-11 |
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.