MicroAire®
Standard Blade Assembly, SmartRelease
8manufacturers in China registered for this device type
19catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Microaire Surgical Instruments LLC, United States |
|---|---|
| FDA product code | EMF |
| Device type | Knife, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K211297 |
| Record published | 2022-06-15 |
| Record revised | 2023-10-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 83014 | In distribution | |
| 81014 | In distribution | |
| 85061 | In distribution | |
| 83061 | In distribution | |
| 81026 | In distribution | |
| 83030-1 | In distribution | |
| 81061 | In distribution | |
| 81029 | In distribution | |
| 81010-1 | In distribution | |
| 81010-1 | In distribution | |
| 81151 | In distribution | |
| 83030-6 | In distribution | |
| 81152 | In distribution | |
| 83030 | In distribution | |
| 81010-6 | In distribution | |
| 83014 | In distribution | |
| 83030-1 | In distribution | |
| 81010 | In distribution | |
| 81027 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgistar | Surgistar, Inc. | 285 |
| Surtex | Surtex Instruments Ltd | 189 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 80 |
| Zoll-Dental | Zoll-Dental | 72 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 59 |
| Lazic | Peter Lazic Gmbh | 47 |
| Millennium | Avalign Technologies, Inc. | 40 |
| Aesculap | Aesculap AG | 38 |
| Sklar | Sklar Corporation | 35 |
| Stylus | Surgical Specialties México, S. de R.L. de C.V. | 32 |
| V. Mueller | Steris Corporation | 31 |
| Elmed | Elmed, Inc. | 30 |
Showing 12 of 122. All products under Knife, Surgical
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Microaire Surgical Instruments LLC | UDI-DI | 2025-05-07 | Class II | Under Investigation by firm | Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. | 1,451 eaches |
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.