SwitchPoint Infinity, Isuite
Infinity 3, Lite Video Router
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Agibot Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Stryker Communications, Inc., United States |
|---|---|
| FDA product code | OCS |
| Device type | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K100852 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0678001000 | In distribution | |
| 0678003000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Switchpoint Infinity | Stryker Communications, Inc. | 1 |
| Unity 9100 | Cogentix Medical, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100852 | 2010-05-06 |
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.