FDA Product Code
FDA Product Code MQE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.6100
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. | 2026-06-15 | Traditional | PDF ↗ |
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-11-15 | Traditional | PDF ↗ |
| K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | Zhejiang Horizon Medical Technology Co., Ltd. | 2024-02-22 | Traditional | PDF ↗ |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | Allwin Medical Devices, Inc. | 2019-11-25 | Traditional | PDF ↗ |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-06-12 | Special | PDF ↗ |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-05-10 | Traditional | PDF ↗ |
| K171625 | Single Lumen Ovum Aspiration Needles | Willian A. Cook Australia Pty, Ltd. | 2018-01-12 | Special | PDF ↗ |
| K171611 | Double Lumen Ovum Aspiration Needles | William A. Cook Australia Pty. , Ltd. | 2017-12-15 | Special | PDF ↗ |
| K172050 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2017-11-21 | Traditional | PDF ↗ |
| K162881 | Kitazato OPU Needles | Kitazato Corporation | 2017-07-11 | Traditional | PDF ↗ |
| K161970 | Follicle Aspiration Set | Vitrolife Sweden AB | 2017-06-14 | Traditional | PDF ↗ |
| K141365 | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN | William A. Cook Australia Pty. , Ltd. | 2014-08-07 | Special | PDF ↗ |
| K112462 | KITAZATO OPU NEEDLE | Kitazato Medical Co., Ltd. | 2012-11-26 | Traditional | PDF ↗ |
| K082727 | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN | Vitrolife Sweden AB | 2009-02-06 | Traditional | PDF ↗ |
| K051742 | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH | Inntec, Inc. | 2005-10-07 | Abbreviated | PDF ↗ |
| K032208 | MONA LISA ASPIRATION NEEDLE | Fertility Technology Resources, Inc. | 2003-12-09 | Traditional | PDF ↗ |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | Rocket Medical Plc | 2003-08-08 | Traditional | PDF ↗ |
| K031622 | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS | Portex , Ltd. | 2003-06-26 | Traditional | PDF ↗ |
| K023930 | COOPERSURGICAL OOCYTE RECOVERY NEEDLES | CooperSurgical, Inc. | 2003-01-22 | Traditional | PDF ↗ |
| K013497 | FAS SET #4551 | Gynetics Medical Products NV | 2001-11-09 | Traditional | PDF ↗ |
| K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S | Sims Portex , Ltd. | 2001-08-03 | Traditional | PDF ↗ |
| K003056 | OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 | Labotect Labor-Technik Gottingen | 2000-12-13 | Traditional | PDF ↗ |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | Rocket Medical Plc | 2000-04-19 | Traditional | PDF ↗ |
| K000628 | WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 | Sims Portex , Ltd. | 2000-03-13 | Traditional | PDF ↗ |
| K991271 | OOCYTE ASPIRATION NEEDLE | Casmed UK | 2000-03-08 | Traditional | PDF ↗ |
| K994417 | OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING | Cook Urological, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K992308 | OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 | Lifetek Medical, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K991020 | <GENX> DOUBLE LUMEN NEEDLE | <Genx> Intl., Inc. | 1999-09-09 | Traditional | PDF ↗ |
| K991262 | <GEN>SINGLE LUMEN NEEDLE | <Genx> Intl., Inc. | 1999-09-09 | Traditional | PDF ↗ |
| K991264 | <GENX> SINGLE LUMEN SIDEPORT NEEDLE | <Genx> Intl., Inc. | 1999-09-09 | Traditional | PDF ↗ |
| K991273 | SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE | Swemed Lab International AB | 1999-08-18 | Traditional | PDF ↗ |
| K990913 | HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU | Laboratoires Prodimed | 1999-06-08 | Traditional | PDF ↗ |
| K983593 | OVUM PICK-UP ASPIRATION NEEDLES | Cook Ob/Gyn | 1999-01-21 | Traditional | PDF ↗ |
Product code MQE · Class II · Obstetrics/Gynecology. Data: openFDA.