Cook
Ovum Aspiration Needle, Double Lumen
3manufacturers in China registered for this device type
71catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | William A. Cook Australia PTY, Ltd., Australia |
|---|---|
| FDA product code | MQE |
| Device type | Needle, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K983593 |
| Record published | 2016-09-24 |
| Record revised | 2026-07-28 (version 6) |
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 | Special storage condition: Store in dark, dry, cool place |
| Distribution end date | 2022-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G55788 | In distribution | |
| G55797 | In distribution | |
| G55480 | In distribution | |
| G55478 | In distribution | |
| G48363 | In distribution | |
| G38436 | In distribution | |
| G38428 | In distribution | |
| G55487 | In distribution | |
| G34174 | In distribution | |
| G44360 | In distribution | |
| G55791 | In distribution | |
| G55787 | In distribution | |
| G38432 | In distribution | |
| G55483 | In distribution | |
| G44355 | In distribution | |
| G55497 | In distribution | |
| G55792 | In distribution | |
| G38845 | In distribution | |
| G55790 | In distribution | |
| G55490 | In distribution | |
| G55786 | In distribution | |
| G55796 | In distribution | |
| G55493 | In distribution | |
| G55253 | In distribution | |
| G55251 | In distribution | |
| G55489 | In distribution | |
| G55798 | In distribution | |
| G55252 | In distribution | |
| G55785 | In distribution | |
| G55789 | In distribution | |
| G55248 | In distribution | |
| G38435 | In distribution | |
| G34175 | In distribution | |
| G55491 | In distribution | |
| G38437 | In distribution | |
| G55477 | In distribution | |
| G55795 | In distribution | |
| G55496 | In distribution | |
| G38427 | In distribution | |
| G38433 | In distribution | |
| G34186 | In distribution | |
| G38430 | In distribution | |
| G55476 | In distribution | |
| G55475 | In distribution | |
| G55488 | Withdrawn | |
| G55494 | Withdrawn | |
| G55495 | Withdrawn | |
| G55492 | Withdrawn | |
| G55250 | Withdrawn | |
| G55484 | Withdrawn | |
| G55472 | Withdrawn | |
| G44358 | Withdrawn | |
| G55793 | Withdrawn | |
| G55481 | Withdrawn | |
| G44357 | Withdrawn | |
| G55249 | Withdrawn | |
| G55784 | Withdrawn | |
| G55485 | Withdrawn | |
| G55794 | Withdrawn | |
| G55783 | Withdrawn | |
| G44359 | Withdrawn | |
| G55474 | Withdrawn | |
| G55486 | Withdrawn | |
| G44356 | Withdrawn | |
| G38434 | Withdrawn | |
| G38681 | Withdrawn | |
| G55482 | Withdrawn | |
| G55473 | Withdrawn | |
| G38608 | Withdrawn | |
| G38429 | Withdrawn | |
| G55479 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Follicle Aspiration Set Single Lumen | Vitrolife Sweden AB | 40 |
| Follicle Aspiration Set, Double Lumen | Vitrolife Sweden AB | 28 |
| Wallace | ICU Medical, Inc | 20 |
| Kitazato OPU Needle with Connection Tube, Type2-v17 | Kitazato Corporation | 18 |
| Labotect | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | 16 |
| Kitazato OPU Needle | Kitazato Corporation | 12 |
| Follicle Aspiration Set Reduced Single Lumen | Vitrolife Sweden AB | 11 |
| Follicle Aspiration Set Single Lumen, Luer | Vitrolife Sweden AB | 9 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 8 |
| 17G Wallace Dual Lumen Oocyte Recovery Set | Coopersurgical, Inc. | 3 |
| ACE-M | Allwin Medical Devices, Inc. | 3 |
| Vacuum Pump Tubing | Vitrolife Sweden AB | 3 |
Showing 12 of 65. All products under Needle, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171611 | 2017-12-15 |
| K141365 | 2014-08-07 |
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.