ViroSafe 12
Smoke Evacuation Filter - Dual male ports 7/8 in (22 mm) and 1-1/4 in (32 mm)
3manufacturers in China registered for this device type
1catalogue number
21510(k) clearances naming this product 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 | Buffalo Filter Co., Inc., United States |
|---|---|
| FDA product code | FYD |
| Device type | Apparatus, Exhaust, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5070 |
| Record published | 2016-09-23 |
| Record revised | 2022-04-22 (version 3) |
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 |
| Packaging | Case |
| Distribution end date | 2022-04-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VS12D01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 57 |
| 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 |
Showing 12 of 142. All products under Apparatus, Exhaust, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131402 | 2014-03-03 |
| K000904 | 2000-06-08 |
| K983298 | 1999-08-16 |
| K983333 | 1999-08-11 |
| K983364 | 1999-08-11 |
| K943226 | 1995-07-10 |
| K943227 | 1995-07-07 |
| K930062 | 1993-11-30 |
| K930058 | 1993-11-30 |
| K930063 | 1993-11-12 |
| K930065 | 1993-11-12 |
| K930066 | 1993-11-12 |
| K930060 | 1993-11-12 |
| K930064 | 1993-11-12 |
| K930041 | 1993-11-03 |
| K930061 | 1993-11-02 |
| K930040 | 1993-11-02 |
| K930450 | 1993-10-29 |
| K930059 | 1993-10-29 |
| K924731 | 1993-09-13 |
| K924732 | 1993-09-13 |
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.