Clarus Cholangiogram Catheter Kit

FDA 510(k) K925742 · Clarus Medical Systems, Inc.

Unknown

510(k) numberK925742

Submission

Device name
Clarus Cholangiogram Catheter Kit
Applicant
Clarus Medical Systems, Inc.
Minneapolis, MN, US
Received
November 13, 1992
Decision date
June 1, 1993
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GBZ – Catheter, Cholangiography
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

Other 510(k)s with product code GBZ

510(k)DeviceApplicantDecision
K973621Pre-View Cholangiography ClampGBZ · Traditional Nashville Surgical Instruments12/17/1997SE
K944790Flexible Laparoscopic Cholangiography CatheterGBZ · Traditional Applied Medical Resources11/29/1994SE
K942450EndopathGBZ · Traditional Ethicon Endo-Surgery, Inc.08/05/1994SE
K932228Microvasive Insurg Chloangiographic CatheterGBZ · Traditional Boston Scientific Corp08/10/1993SE
K926217Terumo Angiographic Catheter for Laporoscopic UseGBZ · Traditional Terumo Medical Corp.07/13/1993SE
K926143Angiolapcath Cholangiography KitGBZ · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic07/07/1993SESK
K924212Stryker Endoscopy Cholangiogram KitGBZ · Traditional Stryker Corp.07/07/1993SESK
K924981Operative Cholangiogram CatheterGBZ · Traditional Taut, Inc.04/06/1993SE
K924480Cholangiography ClampGBZ · Traditional Applied Medical Resources03/03/1993SE
K924128Cholangiography CatheterGBZ · Traditional Applied Medical Resources02/10/1993SE

More from Applied Medical Resources

510(k)DeviceDecision
K980588Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional 08/18/1998SE
K974579Percscope Model 2600HRX · Traditional 02/18/1998SE
K971584Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional 05/23/1997SE
K971455Clarus Model 5197 SightliteFTI · Traditional 05/20/1997SE
K960915Clarus Neuropen Endoscopic Placement Kit Model 2125-XXXGWG · Traditional 12/24/1996SE
K962255Clarus Murphypen ENDOSCOPE(2127-XXX)EOB · Traditional 09/11/1996SE
K955598Clarus Spinepen Model 2126GWG · Traditional 02/06/1996SE
K953685Instrument ScopeGWG · Traditional 10/12/1995SE
K945633Neuro Channel Endoscope Model 2232GWG · Traditional 09/19/1995SE
K945296Clarus Phoenix Neuro Endoscope Model 2160GWG · Traditional 07/14/1995SE

Questions and answers

When was Clarus Cholangiogram Catheter Kit cleared by the FDA?

Clarus Cholangiogram Catheter Kit (K925742) received a 510(k) decision of Unknown on June 1, 1993, 200 days after the submission was received.

What is the product code of K925742?

The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.