BougieCap
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible…
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (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 |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Ovesco Endoscopy AG, Germany |
|---|---|
| FDA product code | KNQ |
| Device type | Dilator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-05 |
| Record revised | 2022-09-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Folding box of 3, pack of 3 |
| Sizes | Length 14.7 to 35 mm; outer diameter 7.1 to 16 mm |
| Distribution end date | 2022-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13/14 | mounting depht of the cap: 9 mm | In distribution |
| 9/10 | mounting depht of the cap: 5.5 mm | In distribution |
| 15/16 | Outer plateau diameters: 15 mm / 16 mm | In distribution |
| 11/12 | mounting depht of the cap: 9 mm | In distribution |
| 17/18 | Outer plateau diameters: 17 mm / 18 mm | In distribution |
| 7/8 | mounting depht of the cap: 5.5 mm | In distribution |
| 10 | mounting depht of the cap: 5 mm | Withdrawn |
| 14 | mounting depht of the cap: 9 mm | Withdrawn |
| 16 | Outer Diameter 16 mm | Withdrawn |
| 7 | Outer Diameter 7.1 mm | Withdrawn |
| 8 | mounting depht of the cap: 5 mm | Withdrawn |
| 12 | Outer Diameter 12 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable Dilation Balloon | Micro-Tech (Nanjing) Co., Ltd. | 99 |
| Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 37 |
| Quantum TTC | Cook Incorporated | 27 |
| Savary Gilliard | Cook Incorporated | 26 |
| SafeGuide® | Diversatek Healthcare Inc | 25 |
| Eliminator | ConMed Corporation | 21 |
| ABC Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Flex-Ez Over the Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Flex-Ez Stylet Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Elation 5™ | Merit Medical Systems, Inc. | 18 |
| SafeGuide® Single | Diversatek Healthcare Inc | 16 |
| Conmed CleanGuide | Jiangsu Grit Medical Technology Co., Ltd. | 16 |
Showing 12 of 40. All products under Dilator, Esophageal
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.