Scipro(Tm) Flexible Stone Dislodger and Retrieval Set

FDA 510(k) K001563 · Scion Cardiovascular, Inc.

Substantially Equivalent

510(k) numberK001563

Submission

Device name
Scipro(Tm) Flexible Stone Dislodger and Retrieval Set
Applicant
Scion Cardiovascular, Inc.
Miami, FL, US
Received
May 19, 2000
Decision date
November 22, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FGO – Dislodger, Stone, Flexible
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4680
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FGO

510(k)DeviceApplicantDecision
K970121Stone Dislodger, BasketFGO · Traditional Boston Scientific Corp04/02/1997SE
K963750Retrieval SnareFGO · Traditional Boston Scientific Corp11/22/1996SE
K962676Disposable Endoscopic Retrieval DeviceFGO · Traditional United States Endoscopy Group, Inc.10/04/1996SE
K951309Stone Dislodger, BasketFGO · Traditional Boston Scientific Corp05/17/1995SE
K933261Grasping ForcepsFGO · Traditional Surgitek01/11/1994SE
K934598Grasping Forceps or Retrieval ForcepsFGO · Traditional Annex Medical, Inc.01/07/1994SE
K921295Intravenous Catheters ModificationsFGO · Traditional Critikon Company, LLC05/17/1993SE
K922542Grasping ForcepsFGO · Traditional Surgitek08/19/1992SE
K914112Metal Ureteral Basket Stone Dislodger, Flat WireFGO · Traditional Annex Medical, Inc.02/28/1992SE
K914111Metal Ureteral Basket Stone Dislodger, HelicalFGO · Traditional Annex Medical, Inc.02/28/1992SE

Questions and answers

When was Scipro(Tm) Flexible Stone Dislodger and Retrieval Set cleared by the FDA?

Scipro(Tm) Flexible Stone Dislodger and Retrieval Set (K001563) received a 510(k) decision of Substantially Equivalent on November 22, 2000, 187 days after the submission was received.

What is the product code of K001563?

The FDA product code is FGO – Dislodger, Stone, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4680.