Optimos™ Cystotome
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into…
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Zhejiang Soudon Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
Record
| Listed by | Taewoongmedical.co., Ltd. |
|---|---|
| FDA product code | KNS |
| Device type | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4300 |
| 510(k) | K223256 |
| Record published | 2023-04-18 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OCT1907 | In distribution | |
| OCT1906 | In distribution | |
| OCT1908 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 93 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Hangzhou AGS MedTech Co., Ltd. | 73 |
| Sphincterotome short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | 73 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 72 |
| Single Use Preloaded Sphincterotome V(Distal Wireguided) | Olympus Medical Systems Corp. | 40 |
| Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 40 |
| Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 40 |
| Single Use 3-Lumen Sphincterotome V | Olympus Medical Systems Corp. | 37 |
| Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Single Use Sphincterotome V(Distal Wireguided) | Olympus Medical Systems Corp. | 20 |
| Cook | Cook Incorporated | 18 |
| Olympus | Olympus Winter & IBE Gmbh | 18 |
Showing 12 of 177. All products under Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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.