O’Brien
O'Brien Suprapubic Peel-Away, Access Set
19manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (10), Shanghai (4), Zhejiang (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Seplou (Zhuhai) Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Zhejiang Yigao Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Eternal (Shanghai) Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
Showing 12 of 19. All 19 manufacturers in China registered for Endoscopic Access Overtube, Gastroenterology-Urology
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | FED |
| Device type | Endoscopic Access Overtube, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-06-11 (version 3) |
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 |
|---|---|---|
| G16123 | In distribution | |
| G16122 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ClearPetra | Well Lead Medical Co., Ltd. | 175 |
| CoralWell | Macrolux Medical Technology Co., Ltd. | 56 |
| Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 35 |
| Single-use Ureteral Access Sheath | Shenzhen Hugemed Medical Technical Development Co., Ltd. | 25 |
| Flexor | Cook Incorporated | 25 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 24 |
| Flexor Parallel | Cook Incorporated | 21 |
| Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 20 |
| Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 18 |
| Guardus | Us Endoscopy | 16 |
| Porges Coloplast | Coloplast A/S | 14 |
| Forté® AXP Access Sheath | Applied Medical Resources Corp. | 13 |
Showing 12 of 66. All products under Endoscopic Access Overtube, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182403 | 2019-05-29 |
| K172217 | 2017-12-13 |
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 |
|---|---|---|---|---|---|
| 2007-01-05 | Not classified | Other | Lack of assurance of sterility, as the packages may not have been sealed. | 4 | 2008-05-01 |
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.