Endo Optiks®
20 Gauge Wide Field Illuminated Laser Probe
2manufacturers in China registered for this device type
25catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | HQP |
| Device type | Unit, Cautery, Thermal, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4115 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K910532 |
| Record published | 2016-09-20 |
| Record revised | 2023-11-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VPH230A | In distribution | |
| OME200SMAHRXA | In distribution | |
| OME200SMAVA | In distribution | |
| OME200LA | In distribution | |
| OME200SMAXVA | In distribution | |
| OME200HRA | In distribution | |
| VP200WA | In distribution | |
| OME20LA | In distribution | |
| OME200LVA | In distribution | |
| OME200SMAXA | In distribution | |
| VP230WA | In distribution | |
| VPH230LA | In distribution | |
| VPH250A | In distribution | |
| OME500SMAHRXA | In distribution | |
| OME230SMAHRXA | In distribution | |
| OME2000 | In distribution | |
| OME230HRA | In distribution | |
| OME4000 | In distribution | |
| OME200SMAEA | In distribution | |
| OME200SMAHRXVA | In distribution | |
| OME200SMAHRVA | In distribution | |
| OME230LA | In distribution | |
| OME230SMAXA | In distribution | |
| OME200SMAHRA | In distribution | |
| OME500SMAHRXVA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bovie | Aspen Surgical Products, Inc. | 28 |
| Accu-Temp® | Beaver-Visitec International, Ltd | 12 |
| Kirwan | Kirwan Surgical Products, LLC. | 8 |
| BVI | Beaver-Visitec International, Ltd | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Pro Advantage | National Distribution & Contracting Inc | 3 |
| Argent | Mckesson Medical-Surgical Inc. | 3 |
| Henry Schein | Henry Schein, Inc. | 3 |
| Medichoice | Owens & Minor Distribution, Inc. | 2 |
| Summit Medical | Summit Medical LLC | 2 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 2 |
| Hotsy | Shippert Medical Technologies Corp. | 2 |
Showing 12 of 14. All products under Unit, Cautery, Thermal, Battery-Powered
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 |
|---|---|---|---|---|---|
| 2018-07-19 | Class II | Nonconforming Material/Component | A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient. | 800 units | 2019-05-23 |
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.