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510(k) K001563

SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET by Scion Cardiovascular, Inc. — Product Code FGO

K001563 is an FDA 510(k) premarket notification submitted by Scion Cardiovascular, Inc. for the device "SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET". The FDA issued a decision of Substantially Equivalent on November 22, 2000. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2000
Date Received
May 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances for product code FGO

  • K970121 — STONE DISLODGER, BASKET (April 2, 1997)
  • K963750 — RETRIEVAL SNARE (November 22, 1996)
  • K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (October 4, 1996)
  • K951309 — STONE DISLODGER, BASKET (May 17, 1995)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914110 — GRASPING FORCEPS (February 28, 1992)
  • K914111 — METAL URETERAL BASKET STONE DISLODGER, HELICAL (February 28, 1992)

FDA data resources