Home / 510(k) Clearances / K930349

510(k) K930349

STONE RETRIEVAL BASKET by Endomedix — Product Code FFL

K930349 is an FDA 510(k) premarket notification submitted by Endomedix for the device "STONE RETRIEVAL BASKET". The FDA issued a decision of Substantially Equivalent on June 9, 1993. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Endomedix has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1993
Date Received
January 25, 1993
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 Endomedix

  • K934170 — ENDOMEDIX Y-ADAPTER (January 11, 1994)
  • K934623 — ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA (December 2, 1993)
  • K930499 — GRASPING FORCEPS FLEXIBLE STONE DISLODGER (August 16, 1993)
  • K926004 — ENDOSCOPE AND ACCOSSORIES (February 10, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)
  • K922082 — LAPAROSCOPIC INTRODUCER (August 3, 1992)

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)
  • K082803 — COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (November 13, 2008)
  • 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)

FDA data resources