Apollo
APOLLO Papillotome, Double Lumen, 20mm Tapered Tip/20mm Monofilament Cutting Wire
7manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | KNS |
| Device type | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K982557 |
| Record published | 2016-09-24 |
| Record revised | 2024-08-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 30 to 75 % RH; Handling environment temperature 60 to 80 °F; Handling environment humidity up to 85 % RH; Handling environment temperature -20 to 140 °F; Storage environment temperature 50 to 90 °F; Handling environment temperature 16 to 27 °C |
| Sizes | Length 5 to 30 mm; outer diameter 0.035 in; outer diameter 0.889 mm |
| Distribution end date | 2022-06-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7104AC | 2.3 – 1.5 Millimeter Catheter Gauge | In distribution |
| 7105AC | Outer Diameter 0.889 mm | In distribution |
| 007102 | Outer Diameter 0.035 in | Withdrawn |
| 007103 | Outer Diameter 0.889 mm | Withdrawn |
| 007101 | Outer Diameter 0.035 in | Withdrawn |
| 7101AC | 7 – 4.5 French Catheter Gauge | Withdrawn |
| 050063 | 2.3 – 1.8 Millimeter Catheter Gauge Diameter | Withdrawn |
| 007100 | 20 Millimeter Cutting wire Length | Withdrawn |
| 050053 | 7 – 5.5 French Catheter Gauge Diameter | Withdrawn |
| 7100AC | Length 5 mm | Withdrawn |
| 050071 | 7 – 5.5 French Catheter Gauge Diameter | Withdrawn |
| 050064 | Length 8 mm | Withdrawn |
| 050054 | Length 8 mm | Withdrawn |
| 050073 | Length 8 mm | Withdrawn |
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.