GelPOINT Path Transanal Access Platform
Transanal Access Platform with Insufflation Stabilization Bag
3manufacturers in China registered for this device type
5catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | FER |
| Device type | Anoscope And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2018-04-03 |
| Record revised | 2018-11-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 4 to 15 cm |
| Distribution end date | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CNB10 | Length 4 cm | In distribution |
| CNB11 | Length 5.5 cm | In distribution |
| CNB12 | Length 9 cm | In distribution |
| CNO11 | Length 5.5 cm | Withdrawn |
| CNO12 | Length 15 cm | Withdrawn |
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 |
| 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 |
|---|---|
| K200021 | 2021-01-06 |
| K171701 | 2017-07-20 |
| K133393 | 2014-01-02 |
| K110792 | 2011-05-23 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-12-12 | Class II | Device Design | Unintentional shifting of the tip insulation of the firm’s electrosurgical probes. | 39 units Domestically and 112 units Internationally | 2021-01-22 |
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.