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510(k) K082803

COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 by Percutaneous Systems, Inc. — Product Code FFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2008
Date Received
September 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Basket, Ureteral, Metal
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances by Percutaneous Systems, Inc.

  • K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (May 16, 2011)
  • K052134 — CYSTOGLIDE DILATING INTRODUCER SHEATH (September 22, 2005)
  • K042877 — MICROVERTER URETERAL ACCESS SHEATH (November 16, 2004)
  • K040519 — SLIP UROLOGY CATHETER (May 20, 2004)
  • K040520 — SLIP UROLOGY INTRODUCER SHEATH (May 20, 2004)

Other clearances for product code FFL

  • K190492 — Peralta Stone Removal Catheter (July 18, 2019)
  • K172299 — Accordion Piccolo Stone Management Device (September 19, 2017)
  • K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (May 16, 2011)
  • K052048 — ACCORDION (September 13, 2005)
  • K012581 — REPROCESSED STONE RETRIEVAL BASKETS (February 14, 2002)
  • K972091 — AMS FOREIGN BODY EXTRATOR (August 29, 1997)
  • K970489 — COMEG ENDOSCOPY GRASPING FORCEPS (March 19, 1997)
  • K962387 — OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (July 31, 1996)
  • K961248 — BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BA (May 28, 1996)
  • K955049 — OLYMPUS FG-45/46-1 GRASPING FORCEPS (December 15, 1995)