Protech L
Scope ProTech Large covers the distal end of a compatible endoscope during storage and transport. It protects the tip, lens and bending section from mechanical damage after reprocessing.…
Scope ProTech Large covers the distal end of a compatible endoscope during storage and transport. It protects the tip, lens and bending section from mechanical damage after reprocessing. The listed INOV8-028L is intended for endoscopes approximately 8.7 to 14.7 mm in diameter.
The protector is molded from soft polypropylene and slides over the scope’s distal end. Its open design allows the covered components to aerate. Identification tabs distinguish clean and used status during handling.
Supply and Use
The cover is individually packaged, ethylene oxide sterile and single use. It is used by healthcare staff in facilities and must not be left on the endoscope during sterilization. It does not contact the patient during its intended storage and transport use.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | Meditech Endoscopy Ltd, United Kingdom |
|---|---|
| FDA product code | OCU |
| Device type | Endoscopic Storage Cover |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K191011 |
| Record published | 2026-01-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| INOV8-028L | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endo-Boot | Us Endoscopy | 4 |
| andorate® Universal Endoscope Tip Guard | GA Health Company Limited | 2 |
| ProArmor | Us Endoscopy | 2 |
| Protech XL | Meditech Endoscopy Ltd | 1 |
| Protech S | Meditech Endoscopy Ltd | 1 |
| Scope Guard | Gyrus Acmi, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191011 | 2019-05-07 |
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.