FDA.reportPublic FDA data

Chris Li

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30048376863004837686Chris Li1N2027-01-012855 Broadway Dr. Ann Arbor MI US 48104
30462057233046205723CHRIS LI1N2026-01-012855 Broadwalk Drive Ann Arbor, Michigan Ann Arbor MI US 48104

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
234591345251025K260262Injection NeedleFBK2026-05-29
234591669349932K254153Single-use Video Scope; PB Digital ControllerFBN2026-04-03
234591022844741K253832Dilation Balloon CatheterFGE2026-04-24
234591994940255K253139Disposable Distal CapFBN2026-03-19
234591941411592K252492Visualized Access and Delivery Catheter; PB Digital ControllerSHU2026-04-24
234591783940161K251692Advanced Tissue Resection DeviceFDI2026-02-21
234591348983775K250229Dual Action Tissue Closure DevicePKL2025-09-08
234592015010201K243471Extraction BasketLQR2024-12-16
234591540643072K243388Disposable Distal CapFDS2025-06-27
234591316342725K233772Disposable Dual Action Tissue Closure DevicePKL2024-03-19
234591486069441K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatibleFGE2023-09-06
234591407359831K222354Elastic Traction SystemQSW2022-10-03
234591674486573K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN2023-02-16
234591875671735K220424Through the Scope Tracheal Stent SystemJCT2022-07-08
234591548910754K220247Guidewire Locking DeviceODC2022-03-29
234591844709603K220157Disposable Hemostatic Closure Clip DevicePKL2022-06-13
234591315499317K213782Single-Use Video Bronchoscopes, Digital ControllerEOQ2022-07-08
234591679371193K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration NeedleKTI2022-07-20
234591706650345K212852Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration NeedleODG2021-12-06
234591528637809K212748Disposable Dual Action Tissue ClipPKL2022-01-20
234591160110427K212403Tracheal Stent System (Y-Shaped)JCT2021-10-30
234591255231423K211172Single Use Electrosurgical Knife with Fluid Pump SystemGEI2021-12-17
234591734259595K211021Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatibleFGE2022-05-06
234591086735064K210934Sphincterotome / short-wire compatible, Sterile SphincterotomeKNS2021-12-01
234591981190425K202438Ensure Single-Use Coagulation ForcepsKGE2021-03-15
234591254740049K202333Lockado Repositionable Hemostasis ClipPKL2021-01-14
234591033755784K202204Tracheal Stent SystemJCT2021-09-01
234591471959824K200071Blue Beacon Submucosal Injectable SolutionPLL2020-11-03
234592000418660K193601Single Use Electrosurgical KnifeGEI2020-07-24
234591973472773K190030Embrella Endoscopic Distal AttachmentFED2019-03-05
234591444362061K182910Segmented Esophageal Stent SystemESW2019-05-29
234591302437025K182556SureClip Repositionable Hemostasis ClipPKL2018-12-14
234592019346629K180418Reliant(TM) Multistage Dilatation Balloon CatheterFGE2018-10-15
234591132327418K180325Single Use MultiClip DevicePKL2018-06-01
234591617144969K180018Disposable Hot Biopsy ForcepsKGE2018-07-05
234591494557406K172813Esophageal Stent SystemESW2018-05-18
234591531509513K172663Cytology BrushFDX2018-03-05
234591151836038K172309Endoscopic Ultrasound Aspiration NeedleODG2017-09-29
234591231174429K162466LuminScan (TM) Imaging SystemNQQ2016-11-29
234591719956130K162226Reliant Multistage Dilatation Balloon CatheterFGE2017-01-25
234591307906918K161463SureClip(TM) Repositionable Hemostasis ClipPKL2017-01-06
234591728215854K160625Disposable Hot Biopsy ForcepsKGE2016-06-14
234591629180343K152802Grasping ForcepsOCZ2016-01-21
234591627641805K152580rescuenetFDI2015-11-03
234591856581071K152001Sterile Repositionable Hemostasis Clipping DevicePKL2015-12-10
234591498325909K151671Disposable Multistage Dilation Balloon CatheterFGE2015-10-16
234592064640889K150434Injection NeedleFBK2015-06-02
3516442064640889K150434Injection NeedleFBK2015-06-02
234591347962175K150316Polypectomy SnareFDI2015-07-30
3516441347962175K150316Polypectomy SnareFDI2015-07-30
234591097446204K132065INJECTION NEEDLEFBK2014-01-17
234591093550050K123223EC SINGLE USE, POLYPECTOMY SNAREFDI2013-01-10
234591057596990
234591064802707
234591198436227
234591224199379
234591224709165
234591235004518
234591266557392
234591327144467
3516441327144467
234591339242951
234591356632109
234591430439070
234591518926786
234591526018851
234591579026617
234591601838576
234591611475086
234591694364293
234591958712817
234591982818356
234592047100953

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PKL92025-09-08
FGE62026-04-24
FDI52026-02-21
FBK42026-05-29
KGE42021-03-15
FBN32026-04-03
JCT32022-07-08
FDX32018-03-05
GEI22021-12-17
ODG22021-12-06
ESW22019-05-29
SHU12026-04-24
FDS12025-06-27
LQR12024-12-16
QSW12022-10-03
KTI12022-07-20
EOQ12022-07-08
ODC12022-03-29
KNS12021-12-01
PLL12020-11-03
FED12019-03-05
NQQ12016-11-29
OCZ12016-01-21