Product code MQE— Obstetrics/Gynecology
Wallace Dual Lumen Oocyte Recovery System
- Classification name
- Needle, Assisted Reproduction
- Device class
- Class 2
- Regulation
- 21 CFR 884.6100
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 33
- First cleared
- Most recent
Market context for product code MQE
FDA has cleared devices under product code MQE between 1999 and 2026, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2024
- 2019
- 2018
- 2017
- 2014
- 2012
- 2009
- 2005
- 2003
- 2001
- 2000
- 1999
Top applicants under product code MQE
Recent clearances under product code MQE
- K253121 — Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
- K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
- K232163 — Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
- 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)
- K191291 — Wallace Dual Lumen Oocyte Recovery System
- K182959 — Wallace Dual Lumen Oocyte Recovery System
- K171625 — Single Lumen Ovum Aspiration Needles
- K171611 — Double Lumen Ovum Aspiration Needles
- K172050 — Follicle Aspiration Set, Reduced Single Lumen
- K162881 — Kitazato OPU Needles
- K161970 — Follicle Aspiration Set
- K141365 — OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
- K112462 — KITAZATO OPU NEEDLE
- K082727 — FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
- K051742 — OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
- K032208 — MONA LISA ASPIRATION NEEDLE
- K032015 — EMBRYON ULTRASOUND NEEDLE GUIDE
- K031622 — WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
- K023930 — COOPERSURGICAL OOCYTE RECOVERY NEEDLES
- K013497 — FAS SET #4551
- K012068 — WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
- K003056 — OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
- K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
- K000628 — WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
- K991271 — OOCYTE ASPIRATION NEEDLE
- K994417 — OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
- K992308 — OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
- K991020 — <GENX> DOUBLE LUMEN NEEDLE
- K991262 — <GEN>SINGLE LUMEN NEEDLE
- K991264 — <GENX> SINGLE LUMEN SIDEPORT NEEDLE
- K991273 — SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
- K990913 — HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
- K983593 — OVUM PICK-UP ASPIRATION NEEDLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.