AED
2.7mm x 0 Deg, 205mm Endoscope. An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the…
2.7mm x 0 Deg, 205mm Endoscope. An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fiberoptic bundle.
16manufacturers in China registered for this device type
157catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Hunan (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Zhejiang Tiansong Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
Showing 12 of 16. All 16 manufacturers in China registered for Cystoscope And Accessories, Flexible/Rigid
Record
| Listed by | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | FAJ |
| Device type | Cystoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K993689 |
| Record published | 2017-11-20 |
| Record revised | 2019-03-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2025-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-4082 | In distribution | |
| 17-1799 | In distribution | |
| 32-4574 | In distribution | |
| M2700 | In distribution | |
| 5790P | In distribution | |
| 32-4085-ACMI | In distribution | |
| 8805A-S | In distribution | |
| 5727C-L | In distribution | |
| 5727B-L | In distribution | |
| 32-4050 | In distribution | |
| 32-4080 | In distribution | |
| 32-4092 | In distribution | |
| 5727W-L | In distribution | |
| 32-4306 | In distribution | |
| 57-1305 | In distribution | |
| 4135GF | In distribution | |
| S2700 | In distribution | |
| AED27023FG | In distribution | |
| 67161D | In distribution | |
| AED8701534 | In distribution | |
| S8805C | In distribution | |
| AED8702524 | In distribution | |
| FG30C | In distribution | |
| 32-4221-IS | In distribution | |
| A24131-47 | In distribution | |
| AED27023FE | In distribution | |
| 5790A | In distribution | |
| 32-4085 | In distribution | |
| 5727A-L | In distribution | |
| 32-4087 | In distribution | |
| E153 | In distribution | |
| 32-4085LB | In distribution | |
| FB25D | In distribution | |
| AED27023ZE | In distribution | |
| AED8703534 | In distribution | |
| 8805B-SC | In distribution | |
| K-324085 | In distribution | |
| 32-4298 | In distribution | |
| 32-4068 | In distribution | |
| 5705B-W | In distribution | |
| 8805B-A | In distribution | |
| 8805B | In distribution | |
| 4135BF | In distribution | |
| 32-4090 | In distribution | |
| AED8703524 | In distribution | |
| 8805C-HD | In distribution | |
| 32-4222 | In distribution | |
| U5740 | In distribution | |
| 5205B-ACM CLASSIC | In distribution | |
| 32-4211 | In distribution | |
| U5785 | In distribution | |
| 324221RR | In distribution | |
| 5705A | In distribution | |
| 22-2823 | In distribution | |
| 5705B-ACM | In distribution | |
| 32-4229 | In distribution | |
| S-324085 | In distribution | |
| 32-4065 | In distribution | |
| M8805C | In distribution | |
| 324205RR | In distribution | |
| 17-1801 | In distribution | |
| 5705B | In distribution | |
| 32-4115 | In distribution | |
| 8805B-OLY | In distribution | |
| 32-4345 | In distribution | |
| 130013 | In distribution | |
| 120400 | In distribution | |
| 26068 CD | In distribution | |
| M8805B | In distribution | |
| 271746 | In distribution | |
| 27174T | In distribution | |
| AED27072BL | In distribution | |
| 32-4066 | In distribution | |
| 32-4095 | In distribution | |
| 32-4077 | In distribution | |
| 32-4060 | In distribution | |
| 8475 | In distribution | |
| 020-017-2200H | In distribution | |
| 32-4057 | In distribution | |
| 32-4226 | In distribution | |
| 32-4067 | In distribution | |
| S8805B | In distribution | |
| 67161FZ | In distribution | |
| E159 | In distribution | |
| U57MR6L | In distribution | |
| 8805B-HD | In distribution | |
| 32-4110 | In distribution | |
| 32-4055 | In distribution | |
| 32-4075 | In distribution | |
| U5790 | In distribution | |
| U5795 | In distribution | |
| 57-1312 | In distribution | |
| 32-4100 | In distribution | |
| 32-4085-A-SET | In distribution | |
| 27068CD | In distribution | |
| AED410152 | In distribution | |
| A24136-47 | In distribution | |
| AED27175A | In distribution | |
| AED27178A | In distribution | |
| A24121-47 | In distribution | |
| EMRS-26B | In distribution | |
| 271745 | In distribution | |
| AED 27174P | In distribution | |
| 32-4227 | In distribution | |
| EMRS-24B | In distribution | |
| 32-4375 | In distribution | |
| 5790BN | In distribution | |
| U5780 | In distribution | |
| 32-4105 | In distribution | |
| 32-4515 | In distribution | |
| 5705B-OLY | In distribution | |
| 5727A-W | In distribution | |
| 32-4228 | In distribution | |
| 32-4072 | In distribution | |
| AED27071-9 | In distribution | |
| 22-2822 | In distribution | |
| AED11275FE | In distribution | |
| STK32-4085 | In distribution | |
| 5792A | In distribution | |
| 5705C | In distribution | |
| 5705W | In distribution | |
| AED27425ZG | In distribution | |
| 32-4056 | In distribution | |
| 5729A | In distribution | |
| AED27071TJ | In distribution | |
| 5705F | In distribution | |
| 57077QL | In distribution | |
| 5729BL-C | In distribution | |
| 4135PF | In distribution | |
| 32-4069 | In distribution | |
| F/W URT | In distribution | |
| 32-4070 | In distribution | |
| AED27425FG | In distribution | |
| 57012 | In distribution | |
| 5727F-L | In distribution | |
| 120013 | In distribution | |
| A24126-47 | In distribution | |
| 271743 | In distribution | |
| AED27177A | In distribution | |
| 8805B | Withdrawn | |
| 5705B-OLY | Withdrawn | |
| 5205B-ACM CLASSIC | Withdrawn | |
| 5790A | Withdrawn | |
| 57-1312 | Withdrawn | |
| 8805A-S | Withdrawn | |
| 27021O | Withdrawn | |
| 8805B-A | Withdrawn | |
| 5705B-W | Withdrawn | |
| 27502-AED | Withdrawn | |
| 27025GFA | Withdrawn | |
| 27025GF | Withdrawn | |
| M8805B | Withdrawn | |
| 5729BL-C | Withdrawn | |
| 27502 | Withdrawn | |
| 8805B | Withdrawn | |
| 27072F | Withdrawn | |
| 27026CA | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Strauss Surgical | American Medical Endoscopy | 112 |
| Cystoscope And Accessories, Flexible/Rigid | Stryker GmbH | 61 |
| Hopkins | Karl Storz GmbH & Co. KG | 50 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 50 |
| Cystoscopy sheath | Sopro-Comeg GmbH | 42 |
| Cystoscopy instrument | Sopro-Comeg GmbH | 42 |
| Cystoscopy obturator | Sopro-Comeg GmbH | 41 |
| OES Elite | Olympus Winter & IBE Gmbh | 39 |
| Cystoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 39 |
| Accessory for urology | Sopro-Comeg GmbH | 34 |
| Cystoscope | Sopro-Comeg GmbH | 28 |
| Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 28 |
Showing 12 of 138. All products under Cystoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K993689 | 1999-12-15 |
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.