InstaClear
SHEATH, LENS CLEANER ULTRA 70 DEGREES, BOTTOM LIGHT InstaClear bottom light guide for use with Olympus 4 x 175 mm ULTRA scopes (5/PK)
7manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Hunan (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan | Hunan | Manufacturer | 6 |
| Jiana Sterilization Technology (Changsha) Co., Ltd. | Changsha | Hunan | Contract manufacturer | 4 |
| Zhuhai Wesee Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 2 |
| Liaoning Jrsd Commercial AND Trading Co., Ltd. | Shenyang | Liaoning | Manufacturer | 2 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | EOB |
| Device type | Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4760 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K152531 |
| Record published | 2016-10-05 |
| Record revised | 2025-06-09 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LCS1830TPST | In distribution | |
| LCS1800UNST | In distribution | |
| LCS4K70BTOL | In distribution | |
| LCS1830BTST | In distribution | |
| LCS1870TPST | In distribution | |
| LCS1845BTST | In distribution | |
| LCS4K00UNOL | In distribution | |
| LCS1570BTOL | In distribution | |
| LCS1500UNOL | In distribution | |
| LCS4K70TPOL | In distribution | |
| LCS4K45TPOL | In distribution | |
| LCS4K30TPOL | In distribution | |
| LCS1530TPOL | In distribution | |
| LCS1870BTST | In distribution | |
| LCS4K45BTOL | In distribution | |
| LCS1845TPST | In distribution | |
| LCTS100S | In distribution | |
| LCS1570TPOL | In distribution | |
| LCS1530BTOL | In distribution | |
| LCS1545TPOL | In distribution | |
| LCS4K30BTOL | In distribution | |
| LCS1545BTOL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 174 |
| Hopkins | Karl Storz GmbH & Co. KG | 99 |
| Jedmed | Jedmed Instrument Company | 70 |
| Endo-Scrub® | Medtronic Xomed, Inc. | 51 |
| AED | National Advanced Endoscopy Devices, Inc. | 49 |
| Sinuscope | Sopro-Comeg GmbH | 32 |
| Sharpsite | Medtronic Xomed, Inc. | 30 |
| Slide-ON® | Medtronic Xomed, Inc. | 29 |
| Slide-ON® Endosheath® | Medtronic Xomed, Inc. | 28 |
| Sinuscope | Ecleris SRL | 27 |
| Nasopharyngoscope (Flexible Or Rigid) | Pentax of America, Inc. | 26 |
| Flex | Medrobotics Corporation | 24 |
Showing 12 of 147. All products under Nasopharyngoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152531 | 2016-01-15 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2024-04-03 | Class II | Under Investigation by firm | Potential for distal end of the sheath to break off during a procedure. | pending |
| Olympus Corporation of the Americas | 510(k) number | 2024-01-16 | Class II | Under Investigation by firm | Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the | 102,279 units (OUS Only) |
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.