Home / 510(k) Clearances / K090485

510(k) K090485

COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 by Percutaneous Systems, Incorporated — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2009
Date Received
February 25, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Percutaneous Systems, Incorporated

  • K061766 — EXPRESSWAY INTERMITTENT CATHETER (March 9, 2007)
  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)
  • K052048 — ACCORDION (September 13, 2005)
  • K042531 — UPDATED SLIP UROLOGY INTRODUCER SHEATH (February 1, 2005)

Other clearances for product code LQR

  • K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (March 18, 2025)
  • K243471 — Extraction Basket (December 16, 2024)
  • K240192 — Single-use Extraction Baskets (October 15, 2024)
  • K230598 — Stone Extraction Baskets (September 12, 2023)
  • K203322 — SpyGlass Discover Retrieval Basket (May 26, 2021)
  • K201509 — Disposable Stone Extraction basket (December 16, 2020)
  • K191789 — Stonetome Stone Removal Device (July 25, 2019)
  • K182381 — Wilson-Cook Mini Basket (October 30, 2018)
  • K171969 — Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Mem (March 28, 2018)
  • K171915 — Nathanson Transcystic Bile Duct Stone Exploration Pack (March 1, 2018)