Welch Allyn, Inc.
Welch Allyn Rigid Operating Anoscope with Obturator; Light Carrier Not Included; 22 mm x 8.9 cm
3manufacturers in China registered for this device type
39catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | FER |
| Device type | Anoscope And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K810227 |
| Record published | 2021-04-15 |
| Record revised | 2025-07-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901075 | In distribution | |
| 901075 | In distribution | |
| 901117 | In distribution | |
| 901075 | In distribution | |
| 901075 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901075 | In distribution | |
| 901075 | In distribution | |
| 901117 | In distribution | |
| 901075 | In distribution | |
| 901016 | In distribution | |
| 901075 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901075 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901075 | In distribution | |
| 901017 | In distribution | |
| 901117 | In distribution | |
| 901117 | In distribution | |
| 901075 | In distribution | |
| 901117 | In distribution | |
| 901075 | Withdrawn | |
| 901075 | Withdrawn | |
| 901016 | Withdrawn | |
| 901075 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| THD N-Ano Anoscope | THD SPA | 4 |
Showing 12 of 23. All products under Anoscope And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K810227 | 1981-02-19 |
| K770906 | 1977-06-01 |
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.