FDA.reportPublic FDA data

Priscilla Aguilar

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30072000163007200016Priscilla Aguilar1N2027-01-01250 Campus Drive Marlborough MA US 01752

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
983711081561366P010013NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMMNB2001-09-28
983711169909332K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEI1997-08-14
983711603453877K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)HIG2024-07-25
983712056770975K231012CoolSeal TrinityGEI2023-11-15
983711259920593K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)GEI2021-09-07
983712024439993K203640CoolSeal RevealGEI2021-05-06
983711942002579K191281Omni Hysteroscope, Omni Lok cervical sealHIH2019-08-29
983711444738216K190813CrossBay Cervical Dilator Catheter SystemPON2019-08-23
983711296470871K190678TempSureGEI2019-07-24
983711952747785K182365TempSure SystemGEI2018-10-24
983712061981158K181974MyoSure XL Tissue Removal Device for FluentHIH2018-08-23
983711677731182K180825Fluent Fluid Management SystemHIG2018-08-03
983711014821240K180233Eviva Stereotactic Guided Breast Biopsy SystemKNW2018-04-10
983711604967866K173901MyoSure MANUAL Tissue Removal DeviceHIH2018-05-08
983711000257084K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2017-09-20
983711044636491K171262TempSureGEI2017-09-22
983712011353142K163052Brevera Biopsy System with Corlumina Imaging TechnologyKNW2017-03-29
983711219927638K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2015-11-13
983711459820442K152070BioZorb LP MarkerNEU2015-08-26
983711543774113K150169Sertera Biopsy DeviceKNW2015-08-14
983712062679005K143484BioZorb MarkerNEU2015-06-29
983711484614045K142029MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMHIH2014-11-26
983711157181432K132949PELLEFIRMPBX2014-02-20
983711063492400K132665PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IECGEI2013-09-25
983711296992435K131736MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)HIH2013-08-22
983711825535129K131581MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)HIH2013-08-22
983711173477358K122498MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)HIH2012-09-10
983711699439415K121868MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)HIH2012-07-19
983711336422961K120593MYOSURE CONTROL UNITHIH2012-03-23
983711553645570K102768SECRMARK BIOPSY SITE MARKING SYSTEMNEU2010-12-02
983711478958876K102698PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFEGEI2011-01-05
983711356829752K102686MYOSURE ROD LENS SCOPE SEALSHIH2010-10-15
983711784978210K102608SECURMARK BIOPSY SITE MARKING SYSTEMNEU2010-10-08
983711524935363K100559MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMHIH2010-03-30
983711480271230K092405MAMMOSITE MULTI LUMENJAQ2009-08-27
983711738700350K091100MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMHIH2009-10-23
983712032944427K081179MAMMOSITE CAVITY EVALUATION DEVICEJAQ2008-05-09
983711697542181K081070INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEMHIH2008-07-23
983711545831548K073690INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEMHIH2008-04-17
983712015728994K072913SECURMARK BIOPSY SITE IDENTIFICATION SYSTEMNEU2008-01-04
983711110673428K071343ELLMAN NOBLE ALLOY ELECTRODESGEI2008-02-28
983711628930025K062528TISSUE SITE MARKING SYSTEMNEU2007-01-26
983711313689679K042290VACUUM ASSISTED CORE BIOPSY DEVICEKNW2004-10-06
983711238533446K034021VACUUM ASSISTED CORE BIOPSY DEVICEKNW2004-09-08
983711878307570K032067MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAYJAQ2004-02-10
983711971389909K030558MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAYJAQ2003-05-21
983711983225623K023450BIOPSY SITE TISSUE MARKER DEVICENEU2002-12-19
983711838256510K011690MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAYJAQ2002-05-06
983711036700665K010400VACUUM ASSISTED CORE BIOPSY DEVICEKNW2001-07-24
983711055594856
983711225697258
983711337949097
983711398769275
983711410076239
983711572448499
983711680588890
983711738748358
983711769326305
983711942577168
983711978872542
983712012138440
983711673991455
983711773629864
983711831096888
983712021883034

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIH162019-08-29
GEI102023-11-15
NEU72015-08-26
KNW62018-04-10
JAQ52009-08-27
HIG22024-07-25
PON12019-08-23
PBX12014-02-20
MNB12001-09-28