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510(k) K922114

ENDOSCOPIC RETRIEVAL BASKET by Intramed Laboratories, Inc. — Product Code FFL

K922114 is an FDA 510(k) premarket notification submitted by Intramed Laboratories, Inc. for the device "ENDOSCOPIC RETRIEVAL BASKET". The FDA issued a decision of Substantially Equivalent on August 3, 1992. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Intramed Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1992
Date Received
May 5, 1992
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 Intramed Laboratories, Inc.

  • K953258 — TITANIUM HEMOSTATIC CLIP (January 5, 1996)
  • K942457 — GRAFT THROMBECTOMY INSTRUMENTS (February 7, 1995)
  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K925283 — VALVULOTOME (February 10, 1994)
  • K934696 — ANGIOSCOPE (January 18, 1994)
  • K914385 — OPTICAL VALVULOTOME (March 2, 1992)
  • K904465 — FLEXIBLE ARTHROSCOPE (December 20, 1990)
  • K903528 — LAPAROSCOPE (September 4, 1990)
  • K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (August 30, 1990)
  • K901010 — FLEXIBLE CHOLEDOCHOSCOPE (May 22, 1990)

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