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510(k) K891254

UROLOGICAL STONE BASKET by Northgate Research, Inc. — Product Code FFL

K891254 is an FDA 510(k) premarket notification submitted by Northgate Research, Inc. for the device "UROLOGICAL STONE BASKET". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Northgate Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1989
Date Received
March 8, 1989
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 Northgate Research, Inc.

  • K903337 — 1.9 FRENCH LITHOTRIPTER ELECTRODE (November 16, 1990)
  • K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE (October 18, 1989)
  • K891252 — UROLOGICAL LOOP RETRIEVERS (March 22, 1989)
  • K891253 — UROLOGICAL GRASPING FORCEPS (March 22, 1989)
  • K864904 — 3F ELECTRODE (February 10, 1987)
  • K852874 — 5F ELECTRODE(LITHOTRIPTOR) (August 21, 1985)
  • K802322 — MODEL SD-1 DISINTEGRATOR (November 10, 1980)

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