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510(k) K970489

COMEG ENDOSCOPY GRASPING FORCEPS by Comeg Endoscopy — Product Code FFL

K970489 is an FDA 510(k) premarket notification submitted by Comeg Endoscopy for the device "COMEG ENDOSCOPY GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on March 19, 1997. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Comeg Endoscopy has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1997
Date Received
February 10, 1997
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 Comeg Endoscopy

  • K971881 — COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTROD (August 12, 1997)
  • K970764 — COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES (April 22, 1997)

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)
  • 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)

FDA data resources