Erbe
FiAPC® plus A; OD 2.3mm; L 2.2m; 2200 Straight Fire flexible probe w/ filter
65manufacturers in China registered for this device type
152catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Erbe Elektromedizin GmbH, Germany |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K240932 |
| Record published | 2025-10-27 |
| Record revised | 2020-06-05 (version 5) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry; Storage environment temperature -29 to 60 °C; Storage environment temperature -20 to 140 °F; Storage environment humidity 15 to 85 % RH; Handling environment humidity 15 to 85 % RH |
| Packaging | Level: 2 of 10, level: 1 of 10, pack of 5, level: 1 of 50, level: 1 of 5, level 1 of 5 |
| Sizes | Length 25 to 1250 mm; length 1.5 to 3 m; area/surface area 40 to 168 Square centimeter; outer diameter 5 mm |
| Distribution end date | 2025-05-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20180-101 | In distribution | |
| 20195-288 | Length 270.000 mm | In distribution |
| 20132-213 | Length 1.500 m | In distribution |
| 20195-181 | In distribution | |
| 20132-110 | Length 240.000 mm | In distribution |
| 20132-059 | In distribution | |
| 20193-072 | Area/Surface Area 136.000 Square centimeter | In distribution |
| 20220-001 | Length 1250 mm | In distribution |
| 10140-620 | In distribution | |
| 20132-167 | Length 2.200 m | In distribution |
| 20189-027 | In distribution | |
| 20220-100 | Length 1250 mm | In distribution |
| 20132-155 | Length 1.500 m | In distribution |
| 20132-116 | Length 500.000 mm | In distribution |
| 20189-310 | In distribution | |
| 20132-325 | Length 2.2 m | In distribution |
| 20193-070 | Area/Surface Area 168.000 Square centimeter | In distribution |
| 20196-119 | In distribution | |
| 20192-130 | In distribution | |
| 20132-252 | Length 100 mm | In distribution |
| 20132-321 | Length 2.2 m | In distribution |
| 20195-191 | Length 340.000 mm | In distribution |
| 20150-260 | Length 1.900 m | In distribution |
| 20132-215 | Length 2.200 m | In distribution |
| 20195-183 | In distribution | |
| 20132-166 | Length 3.000 m | In distribution |
| 20188-301 | In distribution | |
| 70132-203 | In distribution | |
| 20132-217 | Length 2.200 m | In distribution |
| 10140-400 | In distribution | |
| 20192-126 | In distribution | |
| 20194-085 | In distribution | |
| 20188-007 | In distribution | |
| 20150-215 | Length 1.900 m | In distribution |
| 20132-257 | Length 160 mm | In distribution |
| 21196-119 | In distribution | |
| 20150-110 | Length 2.3 m | In distribution |
| 20195-184 | In distribution | |
| 20132-186 | Length 2.200 m | In distribution |
| 20132-129 | In distribution | |
| 20189-352 | In distribution | |
| 20132-228 | In distribution | |
| 20132-251 | Length 35 mm | In distribution |
| 10140-500 | In distribution | |
| 20132-323 | Length 3.0 m | In distribution |
| 20195-190 | Length 340.000 mm | In distribution |
| 20193-076 | Area/Surface Area 136.000 Square centimeter | In distribution |
| 20193-075 | Area/Surface Area 72.000 Square centimeter | In distribution |
| 20196-118 | In distribution | |
| 20140-007 | Length 700.000 mm | In distribution |
| 20196-067 | In distribution | |
| 20132-219 | Length 3.000 m | In distribution |
| 20183-053 | In distribution | |
| 20196-115 | In distribution | |
| 20132-109 | Length 110.000 mm | In distribution |
| 20132-208 | In distribution | |
| 20183-110 | In distribution | |
| 20132-212 | Length 3.000 m | In distribution |
| 20189-620 | In distribution | |
| 20150-112 | Length 2.3 m | In distribution |
| 20188-350 | In distribution | |
| 20195-298 | Length 260.000 mm | In distribution |
| 10134-000 | In distribution | |
| 20189-351 | In distribution | |
| 20132-254 | Length 350 mm | In distribution |
| 20140-004 | Length 700.000 mm | In distribution |
| 21196-115 | In distribution | |
| 10160-010 | In distribution | |
| 20193-073 | Area/Surface Area 40.000 Square centimeter | In distribution |
| 20132-156 | Length 2.200 m | In distribution |
| 20132-216 | Length 3.000 m | In distribution |
| 20192-135 | In distribution | |
| 20132-157 | Length 2.200 m | In distribution |
| 20188-620 | In distribution | |
| 20196-064 | In distribution | |
| 10140-100 | In distribution | |
| 20189-107 | In distribution | |
| 20220-101 | Length 1250 mm | In distribution |
| 20150-113 | Length 2.3 m | In distribution |
| 20132-256 | Length 250 mm | In distribution |
| 20132-106 | Length 110.000 mm | In distribution |
| 20140-008 | In distribution | |
| 20132-218 | Length 2.200 m | In distribution |
| 10140-610 | In distribution | |
| 10160-000 | In distribution | |
| 20196-126 | In distribution | |
| 20220-011 | Length 1250 mm | In distribution |
| 20189-350 | In distribution | |
| 20132-250 | Length 35 mm | In distribution |
| 20132-324 | Length 2.2 m | In distribution |
| 20132-253 | Length 100 mm | In distribution |
| 20180-110 | In distribution | |
| 20195-286 | Length 200.000 mm | In distribution |
| 20192-134 | In distribution | |
| 20189-305 | In distribution | |
| 20183-068 | In distribution | |
| 20189-311 | In distribution | |
| 20189-353 | In distribution | |
| 20192-125 | In distribution | |
| 10135-000 | In distribution | |
| 20193-084 | Area/Surface Area 85.000 Square centimeter | In distribution |
| 20132-046 | Length 2.500 m | In distribution |
| 20195-185 | In distribution | |
| 20195-189 | In distribution | |
| 20193-071 | Area/Surface Area 72.000 Square centimeter | In distribution |
| 20192-133 | In distribution | |
| 20150-120 | Length 1.9 m | In distribution |
| 20220-010 | Length 1250 mm | In distribution |
| 20189-015 | In distribution | |
| 20188-013 | In distribution | |
| 20195-182 | In distribution | |
| 20150-261 | Length 1.900 m | In distribution |
| 20132-255 | Length 350 mm | In distribution |
| 20187-003 | In distribution | |
| 20195-180 | Length 340.000 mm | In distribution |
| 20160-011 | In distribution | |
| 20189-304 | In distribution | |
| 20220-000 | Length 1250 mm | In distribution |
| 20220-110 | Length 1250 mm | In distribution |
| 20220-111 | Length 1250 mm | In distribution |
| 20195-192 | Outer Diameter 5.000 mm | In distribution |
| 20180-100 | In distribution | |
| 21196-118 | In distribution | |
| 20132-107 | Length 110.000 mm | In distribution |
| 20150-111 | Length 2.3 m | In distribution |
| 20188-102 | In distribution | |
| 20132-113 | Length 300.000 mm | In distribution |
| 20132-214 | Length 2.200 m | In distribution |
| 20193-074 | Area/Surface Area 168.000 Square centimeter | In distribution |
| 20132-209 | In distribution | |
| 20132-158 | Length 2.500 m | In distribution |
| 20196-127 | In distribution | |
| 20132-032 | Length 100.000 mm | Withdrawn |
| 20195-190 | Withdrawn | |
| 20132-255 | Outer Diameter 5 mm | Withdrawn |
| 20132-253 | Length 100 mm | Withdrawn |
| 20132-251 | Length 35 mm | Withdrawn |
| 20132-254 | Outer Diameter 5 mm | Withdrawn |
| 20132-084 | Length 320.000 mm | Withdrawn |
| 20132-034 | Length 320.000 mm | Withdrawn |
| 10140-200 | Withdrawn | |
| 20132-256 | Length 250 mm | Withdrawn |
| 20195-192 | Withdrawn | |
| 20195-191 | Withdrawn | |
| 10140-300 | Withdrawn | |
| 20132-043 | Withdrawn | |
| 20132-054 | Length 35.000 mm | Withdrawn |
| 20132-056 | Length 100.000 mm | Withdrawn |
| 20132-044 | Length 100.000 mm | Withdrawn |
| 20132-031 | Length 25.000 mm | Withdrawn |
| 20132-250 | Length 35 mm | Withdrawn |
| 20132-252 | Length 100 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253915 | 2025-12-18 |
| K251108 | 2025-08-29 |
| K243120 | 2025-06-20 |
| K243451 | 2025-03-21 |
| K242044 | 2024-08-26 |
| K240932 | 2024-08-05 |
| K232033 | 2023-11-29 |
| K191234 | 2019-12-20 |
| K190823 | 2019-05-22 |
| K183445 | 2019-04-04 |
| K150364 | 2016-05-05 |
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.