Koyle
Koyle Diaper Stent Set
9manufacturers in China registered for this device type
2catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Guangdong Ecan Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G17668 | In distribution | |
| G17666 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| Dover | Cardinal Health | 152 |
| MTG | HR Pharmaceuticals Inc. | 59 |
| Cook | Cook Incorporated | 43 |
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 30 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 30 |
| Ureteral Catheter | Well Lead Medical Co., Ltd. | 26 |
| Bardex® Urethral Catheter Robinson Model | C.R. Bard, Inc. | 26 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 24 |
| DeRoyal | Deroyal Industries, Inc. | 23 |
| Bard® Robinson Catheter | C.R. Bard, Inc. | 22 |
Showing 12 of 150. All products under Catheter, Urological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181144 | 2018-06-28 |
| K171810 | 2018-03-07 |
| K171600 | 2018-02-16 |
| K171662 | 2018-02-01 |
| K760858 | 1976-12-06 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-12-13 | Not classified | Packaging process control | The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch. | 25 stents | 2011-01-31 |
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.