Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- MQENeedle, Assisted Reproduction2Product Code
- K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)2Cleared 510(K)
- K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle2Cleared 510(K)
- K190590Allwin 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)2Cleared 510(K)
- K191291Wallace Dual Lumen Oocyte Recovery System2Cleared 510(K)
- K182959Wallace Dual Lumen Oocyte Recovery System2Cleared 510(K)
- K171625Single Lumen Ovum Aspiration Needles2Cleared 510(K)
- K171611Double Lumen Ovum Aspiration Needles2Cleared 510(K)
- K172050Follicle Aspiration Set, Reduced Single Lumen2Cleared 510(K)
- K162881Kitazato OPU Needles2Cleared 510(K)
- K161970Follicle Aspiration Set2Cleared 510(K)
- K141365OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN2Cleared 510(K)
- K112462KITAZATO OPU NEEDLE2Cleared 510(K)
- K082727FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN2Cleared 510(K)
- K051742OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH2Cleared 510(K)
- K032208MONA LISA ASPIRATION NEEDLE2Cleared 510(K)
- K032015EMBRYON ULTRASOUND NEEDLE GUIDE2Cleared 510(K)
- K031622WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS2Cleared 510(K)
- K023930COOPERSURGICAL OOCYTE RECOVERY NEEDLES2Cleared 510(K)
- K013497FAS SET #45512Cleared 510(K)
- K012068WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S2Cleared 510(K)
- K003056OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 322182Cleared 510(K)
- K000205EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES2Cleared 510(K)
- K000628WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS17332Cleared 510(K)
- K991271OOCYTE ASPIRATION NEEDLE2Cleared 510(K)
- K994417OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING2Cleared 510(K)
- K992308OOCYTE RETRIEVAL NEEDLE SET, MODEL 901382Cleared 510(K)
- K991262<GEN>SINGLE LUMEN NEEDLE2Cleared 510(K)
- K991264<GENX> SINGLE LUMEN SIDEPORT NEEDLE2Cleared 510(K)
- K991020<GENX> DOUBLE LUMEN NEEDLE2Cleared 510(K)
- K991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE2Cleared 510(K)
- K990913HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU2Cleared 510(K)
- K983593OVUM PICK-UP ASPIRATION NEEDLES2Cleared 510(K)
- MQFCatheter, Assisted Reproduction2Product Code
- MQGAccessory, Assisted Reproduction2Product Code
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- MQLMedia, Reproductive2Product Code
- MRXSystem, Assisted Reproduction Laser2Product Code
- MTWSystem, Water, Reproduction, Assisted, And Purification2Product Code
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted1Product Code
- NNBNeedle, Reproduction, Assisted, Reprocessed2Product Code
- PBHEmbryo Image Assessment System, Assisted Reproduction2Product Code
- OYOCulture, Intravaginal, Assisted Reproduction2Product Code
- PUBAccessory, Assisted Reproduction, Exempt2Product Code
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt2Product Code
- PUDLabware, Assisted Reproduction, Exempt2Product Code
- QKHAssisted Reproduction Laminar Flow Workstation2Product Code
- QKIMedia, Reproductive, Exempt2Product Code
- QUJAutomated Cryopreservation Storage System2Product Code
- QYZAt Home Intravaginal Insemination System2Product Code
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FAS SET #4551
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K013497
- 510(k) Type
- Traditional
- Applicant
- GYNETICS MEDICAL PRODUCTS NV
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/9/2001
- Days to Decision
- 18 days
- Submission Type
- Statement