Product code JAQ— Radiology
BIOLUCENT APPLICATOR KIT
- Classification name
- System, Applicator, Radionuclide, Remote-Controlled
- Device class
- Class 2
- Regulation
- 21 CFR 892.5700
- Advisory panel
- Radiology
- Total cleared
- 208
- First cleared
- Most recent
Market context for product code JAQ
FDA has cleared devices under product code JAQ between 1978 and 2026, filed by 52 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
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
Top applicants under product code JAQ
Recent clearances under product code JAQ
1–100 of 208- K262383 — LumenCare Azure
- K252717 — MAASTRO Rectal Applicator Set
- K251037 — Rectal Applicator
- K252884 — Guided Aarhus Applicator Set
- K250299 — CT/ MR Tandem and Ovoid Set
- K250289 — Intracavitary/Interstitial System
- K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400)
- K241764 — Mould Probe MR Safe
- K242961 — Intraluminal Applicator Set
- K243045 — BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
- K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
- K241965 — Catheter Surface Flap Applicator Set (GM11011830)
- K241386 — Heyman Packing Applicator Set (GM11004580)
- K233628 — AOS Interstitial Templates, Needles, and Accessories
- K233626 — AOS Marker Seeds (SMG0242-025)
- K240495 — Flexible Fixation Device for Gynecological Applicators (GM11001960)
- K232623 — Universal Endometrial Applicator Set (GM11009840)
- K232949 — Kelowna GYN and Crook Prostate Templates
- K230155 — Mick Valencia Applicator Set
- K222775 — Aarhus Applicator Set
- K221797 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
- K193240 — Universal Cylinder Applicator Family
- K201272 — Geneva
- K201279 — ASSISTO Universal Applicator Clamping Device
- K200221 — CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
- K191580 — BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
- K183332 — BRAXX Esophageal Brachytherapy Applicator
- K172533 — GM Implant Tubes, Length Cutting Gauge
- K181903 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
- K172675 — Varian Cervical Sleeves
- K180069 — HDR MRI Lumen Marker
- K162499 — Best Instruminal Applicator
- K172611 — Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
- K171631 — Standard Catheter Set
- K162533 — Kelowna GYN and Crook Prostate Templates
- K170203 — System, Applicator, Radionuclide, Remote Controlled
- K162615 — Mould Applicator Set
- K160815 — Interstitial Needles
- K162018 — Surface Applicator Set
- K160610 — Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
- K161688 — Advanced Gynecological Applicator
- K160045 — Heyman Packing Applicator Set
- K161540 — Advanced Breast Template System
- K161576 — Esophagus Bougie Set
- K160516 — Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
- K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template
- K160021 — Varian Sterilization Boxes
- K151022 — Intraluminal Applicator Set
- K152018 — Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
- K151657 — Shielded Applicator Set, Cervical Stop
- K150839 — 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
- K151272 — Henschke Titanium Applicator Set
- K142719 — E-App
- K142986 — SagiNova
- K142330 — Kobold Ring and Tandem Applicator Set
- K141624 — PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
- K142439 — Martinez Prostate Template Set
- K142597 — Vienna System
- K141490 — UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
- K141336 — SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
- K140803 — LUNERAY; CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
- K133922 — GENTLECARE AR APPLICATOR
- K130757 — KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET
- K132889 — FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
- K132874 — LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
- K132097 — BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
- K123912 — KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
- K123941 — KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
- K130251 — ESOPHAGUS BOUGIE SET
- K123815 — SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
- K123442 — XOFT AXXENT CERVICAL APPLICATORS
- K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
- K122236 — VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER
- K120993 — GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER
- K120731 — TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
- K120344 — RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
- K120341 — PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
- K113766 — CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
- K112420 — ONCENTRA PROSTATE 4.0
- K111973 — VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
- K103215 — CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
- K101411 — SAVI PREPARATION DEVICE
- K092534 — ALATUS VAGINAL BALLOON PACKING SYSTEM
- K093291 — VARIAN INTERSTITIAL TITANIUM NEEDLES
- K092822 — CAPRI APPLICATOR
- K092804 — MICROSELECTRON HDR V2, MODEL 105.999
- K092405 — MAMMOSITE MULTI LUMEN
- K092323 — CONTURA CAVITY MAINTENANCE CATHETER
- K091230 — HDR PROSTATE TEMPLATE AND ACCESSORIES
- K091378 — MAMMOSITE II RADIATION THERAPY SYSTEM
- K091598 — LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS
- K091154 — UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,
- K082530 — APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
- K082653 — CENTERING INTRALUMINAL APPLICATOR
- K082264 — CONTURA LUMEN MARKER
- K081677 — SAVI APPLICATOR KIT
- K080934 — VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
- K081179 — MAMMOSITE CAVITY EVALUATION DEVICE
- K081079 — CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
- K080791 — CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
Data sourced from openFDA. This site is unofficial and independent of the FDA.