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510(k) K132383

GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER by Gyrus Acmi, Inc. — Product Code LJE

K132383 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on February 4, 2014. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2014
Date Received
July 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Gyrus Acmi, Inc.

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  • K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-us (March 25, 2024)
  • K231327 — POWERSEAL Sealer and Divider (October 25, 2023)
  • K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperP (January 27, 2023)
  • K212650 — Celeris, Disposable Sinus Debrider (January 19, 2022)
  • K213831 — Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (January 4, 2022)
  • K211401 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed (June 3, 2021)
  • K181696 — ChitoZolve (November 30, 2018)
  • K180086 — Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (March 8, 2018)
  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)

Other clearances for product code LJE

  • K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit (July 3, 2025)
  • K222705 — Introducer Needle (May 22, 2023)
  • K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kit (March 10, 2022)
  • K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (December 17, 2020)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (July 16, 2019)
  • K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Tro (May 17, 2019)
  • K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (March 27, 2019)
  • K181713 — Ultraxx Nephrostomy Balloon Catheter Set (August 17, 2018)

FDA data resources