Air Assist
Air Assist: 1 catalogue number listed by Gastro Concepts, United States, under Anoscope And Accessories. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Gastro Concepts, United States |
|---|---|
| FDA product code | FER |
| Device type | Anoscope And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K242668 |
| Record published | 2025-03-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 39 |
| ESI | FTT Medical, Inc. | 30 |
| THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 18 |
| Pak-its® | Derma Sciences Canada, Inc. | 7 |
| Petrolatum Gauze® | Derma Sciences Canada, Inc. | 7 |
| V. Mueller | Steris Corporation | 6 |
| GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 5 |
| Self-light anoscopes | Sapi MED SPA | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Retractor | Sapi MED SPA | 4 |
| Anoscope | Sapi MED SPA | 4 |
| McKesson | Mckesson Medical-Surgical Inc. | 4 |
Showing 12 of 23. All products under Anoscope And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242668 | 2024-12-13 |
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.