Bovie
Extended Modified Needle Blade Electrode 6'' (15.24CM) 0.75"' (1.90CM)
6manufacturers in China registered for this device type
138catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. | Jinhua | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | HGI |
| Device type | Electrocautery, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K931338 |
| Record published | 2016-09-23 |
| Record revised | 2026-05-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 10 to 75 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Box of 5, pack of 5, box of 25, pack of 25, box of 50, pack of 50 |
| Sizes | Width 5 to 25 mm; length 4 to 20 mm; outer diameter 0.125 to 0.75 in; length 0.15625 to 4 in; length 3 to 4.5 cm; outer diameter 3 to 5 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ES13 | In distribution | ||
| ES47 | In distribution | ||
| E15624 | 10 | In distribution | |
| A804 | 100 | In distribution | |
| ES06 | In distribution | ||
| ES24 | In distribution | ||
| ES07 | In distribution | ||
| ES15 | Width 10 mm | In distribution | |
| ES46 | Width 10 mm | In distribution | |
| A806DE | 100 | In distribution | |
| ES13 | Width 20 mm | In distribution | |
| ES52 | Width 10 mm | In distribution | |
| ES37 | In distribution | ||
| ES48 | In distribution | ||
| ES26-8 | In distribution | ||
| ES51 | Width 13 mm | In distribution | |
| ES25-8 | In distribution | ||
| E16514 | 10 | In distribution | |
| ES40 | In distribution | ||
| ES07 | Outer Diameter 5 mm | In distribution | |
| ES50 | Outer Diameter 0.125 in | In distribution | |
| ES44 | Width 15 mm | In distribution | |
| ES51 | In distribution | ||
| ES20 | In distribution | ||
| ES01 | In distribution | ||
| ES47 | Width 25 mm | In distribution | |
| ES06 | Outer Diameter 3 mm | In distribution | |
| ES02 | In distribution | ||
| ES62 | In distribution | ||
| ES21 | In distribution | ||
| A805 | In distribution | ||
| A804 | 100 | In distribution | |
| ES23 | Outer Diameter 0.3125 in | In distribution | |
| ES11 | In distribution | ||
| ES26 | In distribution | ||
| ES45 | Width 13 mm | In distribution | |
| ES23 | In distribution | ||
| ES58 | In distribution | ||
| ES61 | In distribution | ||
| ES37 | In distribution | ||
| ES55 | In distribution | ||
| ES09 | In distribution | ||
| ES52 | In distribution | ||
| ES62 | Length 4.5 cm | In distribution | |
| E15606 | 10 | In distribution | |
| ES38 | In distribution | ||
| ES14 | In distribution | ||
| A806DE | 100 | In distribution | |
| ESLK | In distribution | ||
| ES42 | In distribution | ||
| ES22 | In distribution | ||
| ES43 | Width 15 mm | In distribution | |
| ES57 | In distribution | ||
| ES26-8 | Outer Diameter 0.75 in | In distribution | |
| ES60 | In distribution | ||
| A806 | 100 | In distribution | |
| ES41 | Width 5 mm | In distribution | |
| ES45 | In distribution | ||
| ES26 | Outer Diameter 0.75 in | In distribution | |
| ES50 | In distribution | ||
| ES63 | Length 4.5 cm | In distribution | |
| ES10 | In distribution | ||
| A805 | In distribution | ||
| ES16 | Width 10 mm | In distribution | |
| ES61HS | In distribution | ||
| ES40 | In distribution | ||
| ES12 | In distribution | ||
| H10108 | In distribution | ||
| ES59 | In distribution | ||
| ES25 | Length 0.5 in | In distribution | |
| ES56 | In distribution | ||
| ES49 | In distribution | ||
| ES60 | Length 3 cm | In distribution | |
| E15646 | 10 | In distribution | |
| ES42 | Width 20 mm | In distribution | |
| ES23-8 | Outer Diameter 0.3125 in | In distribution | |
| H10008 | In distribution | ||
| ES21 | Length 0.15625 in | In distribution | |
| ES54 | Length 4 in | In distribution | |
| ES31 | In distribution | ||
| ES02 | In distribution | ||
| ES12 | Width 20 mm | In distribution | |
| ES03 | In distribution | ||
| ES31 | Width 20 mm | In distribution | |
| E15644 | 10 | In distribution | |
| ES24 | Outer Diameter 0.375 in | In distribution | |
| E15596 | 10 | In distribution | |
| A806 | 100 | In distribution | |
| ES15 | In distribution | ||
| ES16 | In distribution | ||
| E15604 | 10 | In distribution | |
| ES41 | In distribution | ||
| ES08 | Width 5 mm | In distribution | |
| ES38 | In distribution | ||
| ES61HS | In distribution | ||
| ES53 | In distribution | ||
| ES43 | In distribution | ||
| A807 | In distribution | ||
| A807DE | In distribution | ||
| ES14 | Width 5 mm | In distribution | |
| E15594 | 10 | In distribution | |
| H10112 | 100 | In distribution | |
| ES46 | In distribution | ||
| ES63 | In distribution | ||
| E15626 | 10 | In distribution | |
| ES49 | Width 20 mm | In distribution | |
| ES22-8 | Outer Diameter 0.25 in | In distribution | |
| E15614 | 10 | In distribution | |
| ES71 | In distribution | ||
| ES39 | In distribution | ||
| ES61 | Length 3 cm | In distribution | |
| A807 | In distribution | ||
| ES23-8 | In distribution | ||
| ES25-8 | Length 0.5 in | In distribution | |
| ES04 | In distribution | ||
| E16512 | 10 | In distribution | |
| ES22-8 | In distribution | ||
| ES09 | Width 10 mm | In distribution | |
| ES20 | Length 0.1875 in | In distribution | |
| A807DE | In distribution | ||
| ES25 | In distribution | ||
| ES10 | Width 15 mm | In distribution | |
| ES08 | In distribution | ||
| ES53 | Width 15 mm | In distribution | |
| ES54 | In distribution | ||
| ESLK | In distribution | ||
| ES04 | In distribution | ||
| ES24-8 | Outer Diameter 0.375 in | In distribution | |
| ES22 | Outer Diameter 0.25 in | In distribution | |
| ES18 | In distribution | ||
| ES55 | Length 4 in | In distribution | |
| ES44 | In distribution | ||
| ES39 | In distribution | ||
| ES03 | In distribution | ||
| H10012 | 100 | In distribution | |
| ES24-8 | In distribution | ||
| E15616 | 10 | In distribution | |
| ES11 | Width 15 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 27 |
| Electrocautery, Gynecologic (And Accessories) | C R I | 24 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 22 |
| Valleylab | Aspen Surgical Products, Inc. | 20 |
| Argent | Mckesson Medical-Surgical Inc. | 19 |
| Carrera Loop Electrodes | Gynex Corporation | 19 |
| Weck | Teleflex Medical LLC | 18 |
| Radius Loop ELectrodes | Gynex Corporation | 13 |
| Aesculap | Aesculap AG | 11 |
| Leep Radius Electrode | Coopersurgical, Inc. | 10 |
| Premier | Premier Dental Products Co. | 9 |
| Megadyne | Megadyne Medical Products, Inc. | 9 |
Showing 12 of 70. All products under Electrocautery, Gynecologic (And Accessories)
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.