AED
Grasper Forcep w/ Diamond T/C Insert Square. Jaw w/ 1358 Axial Handle
13manufacturers in China registered for this device type
79catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Skonsin Electronics Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Shanghai AnQing Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Guangdong EO Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou | Jiangsu | Specification developer | 4 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
Showing 12 of 13. All 13 manufacturers in China registered for Hysteroscope (And Accessories)
Record
| Listed by | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | HIH |
| Device type | Hysteroscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K141515 |
| Record published | 2017-12-13 |
| Record revised | 2019-03-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2025-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HS2339 | In distribution | |
| 5729B | In distribution | |
| 32-4120 | In distribution | |
| HS2330 | In distribution | |
| HS2500D | In distribution | |
| HS8500 | In distribution | |
| HS2305 | In distribution | |
| HS6030 | In distribution | |
| 2600S | In distribution | |
| HS8521 | In distribution | |
| HS2445 | In distribution | |
| HS2300 | In distribution | |
| 32-4420 | In distribution | |
| 3100-00 | In distribution | |
| HS6040 | In distribution | |
| HS2440 | In distribution | |
| HS2334 | In distribution | |
| 2600G | In distribution | |
| HS2455 | In distribution | |
| 8805B-SH | In distribution | |
| HS2338 | In distribution | |
| HS5700 | In distribution | |
| HS2333 | In distribution | |
| HS2332 | In distribution | |
| 18-2304 | In distribution | |
| HS2459 | In distribution | |
| HS6050 | In distribution | |
| 8829BL | In distribution | |
| 2600C | In distribution | |
| 2600P | In distribution | |
| HS2331 | In distribution | |
| 32-4126 | In distribution | |
| Pending 2 | In distribution | |
| 32-4121 | In distribution | |
| 5729FL | In distribution | |
| 32-4125 | In distribution | |
| 5729F | In distribution | |
| 32-4141 | In distribution | |
| HS2400B | In distribution | |
| 32-4131 | In distribution | |
| 18-2306 | In distribution | |
| VS-0120 | In distribution | |
| 18-2331 | In distribution | |
| 32-4136 | In distribution | |
| HS2310D | In distribution | |
| 32-4140 | In distribution | |
| HS2333 | In distribution | |
| 5729BL-H | In distribution | |
| 2600CB | In distribution | |
| 32-4130 | In distribution | |
| 2600K | In distribution | |
| HS2400C | In distribution | |
| HS2337 | In distribution | |
| 5729BL | In distribution | |
| HS2435 | In distribution | |
| 5729C | In distribution | |
| 18-2332 | In distribution | |
| 32-4135 | In distribution | |
| HS2434 | In distribution | |
| 18-2305 | In distribution | |
| 26153EA | In distribution | |
| C8500-1358 | In distribution | |
| CMK-S | In distribution | |
| 2600F | In distribution | |
| AED27290K | In distribution | |
| 5720AL | In distribution | |
| 1127FE | Withdrawn | |
| HS2331 | Withdrawn | |
| HS5700 | Withdrawn | |
| HS2330 | Withdrawn | |
| 5729BL-H | Withdrawn | |
| 5729FL | Withdrawn | |
| 27050SL | Withdrawn | |
| HS2339 | Withdrawn | |
| HS2338 | Withdrawn | |
| HS2436 | Withdrawn | |
| HS2435 | Withdrawn | |
| HS8500 | Withdrawn | |
| AED27175A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hysteroscope (And Accessories) | Karl Storz GmbH & Co. KG | 255 |
| USA Elite | Gyrus Acmi, Inc. | 79 |
| Olympus | Olympus Winter & IBE Gmbh | 57 |
| Hysteroscope (And Accessories) | Stryker GmbH | 42 |
| TruClear | Covidien LP | 29 |
| Hysteroscopy sheath | Sopro-Comeg GmbH | 28 |
| Hysteroscope (And Accessories) | Richard Wolf Gmbh | 24 |
| Hysteroscope | Sopro-Comeg GmbH | 18 |
| Elite 2 System | Gyrus Acmi, Inc. | 17 |
| Gynecare Versapoint | Ethicon, Inc. | 16 |
| USA Elite System | Gyrus Acmi, Inc. | 11 |
| SlimLine | Gyrus Acmi, Inc. | 10 |
Showing 12 of 177. All products under Hysteroscope (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141515 | 2015-01-07 |
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.