Bovie
Cautery High Temperature 2" Extended Shaft Loop Tip (10/bx)
2manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | HQP |
| Device type | Unit, Cautery, Thermal, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4115 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K121441 |
| Record published | 2024-08-28 |
| Record revised | 2025-12-30 (version 5) |
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, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C; Handling environment humidity 10 to 75 % RH |
| Packaging | Box of 10, pack of 10 |
| Sizes | Shaft length 2 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AA03X | In distribution | ||
| AA03X | In distribution | ||
| AA00 | In distribution | ||
| AA01 | In distribution | ||
| AA21X | In distribution | ||
| AA01 | In distribution | ||
| AA21X | In distribution | ||
| AA02 | In distribution | ||
| AA01X | In distribution | ||
| AA05X | In distribution | ||
| SOSCAA90 | 10 | In distribution | |
| AA04X | In distribution | ||
| AA21 | In distribution | ||
| AA00X | In distribution | ||
| AA02 | In distribution | ||
| AA01X | In distribution | ||
| AA90 | In distribution | ||
| AA21 | In distribution | ||
| AA05 | In distribution | ||
| AA00X | In distribution | ||
| AA00 | In distribution | ||
| AA05 | Shaft Length 2 in | In distribution | |
| AA04 | In distribution | ||
| AA90 | In distribution | ||
| AA04X | In distribution | ||
| AA03 | In distribution | ||
| AA03 | In distribution | ||
| AA04 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endo Optiks® | Beaver-Visitec International, Ltd | 25 |
| Accu-Temp® | Beaver-Visitec International, Ltd | 12 |
| Kirwan | Kirwan Surgical Products, LLC. | 8 |
| BVI | Beaver-Visitec International, Ltd | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Pro Advantage | National Distribution & Contracting Inc | 3 |
| Argent | Mckesson Medical-Surgical Inc. | 3 |
| Henry Schein | Henry Schein, Inc. | 3 |
| Medichoice | Owens & Minor Distribution, Inc. | 2 |
| Summit Medical | Summit Medical LLC | 2 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 2 |
| Hotsy | Shippert Medical Technologies Corp. | 2 |
Showing 12 of 14. All products under Unit, Cautery, Thermal, Battery-Powered
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.