PenAdapt
Electrosurgery Pencil Adaptor Cut Back
3manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | 2024-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 25 |
| Sizes | Length 1 to 10 ft; lumen/inner diameter 0.375 in |
| Distribution end date | 2022-04-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PA2010 | Length 10 ft | Withdrawn |
| PA1025 | Length 1 ft | Withdrawn |
| PA2010B | Length 10 ft | Withdrawn |
| PA2010CB | Length 10 ft | Withdrawn |
| PA1025CB | Lumen/Inner Diameter 0.375 in | Withdrawn |
| PA2010BCB | Length 10 ft | Withdrawn |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.