Microtek
Laser Handset Tubing SET 7/8 X 16'' Coherent Laser, 1-EACH
3manufacturers in China registered for this device type
57catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Microtek Medical LLC, United States |
|---|---|
| FDA product code | FYD |
| Device type | Apparatus, Exhaust, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5070 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K001082 |
| Record published | 2017-01-16 |
| Record revised | 2025-02-05 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Store under normal warehouse conditions. |
| Packaging | Pack of 10, pack of 3, pack of 12, pack of 24, pack of 5, pack of 4 |
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Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgimedics® | Coastal Life Technologies, Inc. | 23 |
| Virosafe | ConMed Corporation | 22 |
| Buffalo Filter | Buffalo Filter Co., Inc. | 22 |
| ACU-Evac | Acuderm, Inc. | 21 |
| Neptune | Stryker GmbH | 14 |
| RapidVac | Covidien LP | 12 |
| Megadyne | Megadyne Medical Products, Inc. | 12 |
| Geiger Smoke Evacuator Filter | Dermatologic LAB AND Supply, Inc. | 12 |
| Apparatus, Exhaust, Surgical | Stryker GmbH | 11 |
| Apparatus, Exhaust, Surgical | ConMed Corporation | 10 |
| Conmed Buffalo Filter | ConMed Corporation | 10 |
| Steris | I.C. Medical, Inc. | 9 |
Showing 12 of 142. All products under Apparatus, Exhaust, Surgical
Recalls Naming This Product
10 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 | Closed |
|---|---|---|---|---|---|---|---|
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 270 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 303 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 32496 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 30796 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 56904 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 5889 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 3180 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 6540 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 9168 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2010-05-25 | Not classified | Other | Product labeled as sterile was distributed without sterilization. | 2 cases of 10 units | 2010-08-12 |
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.