Wurtz Choley Clip (TM)
FDA 510(k) K901520 · Cd Medical, Inc.
510(k) numberK901520
Submission
- Device name
- Wurtz Choley Clip (TM)
- Applicant
- Cd Medical, Inc.
Hoffman Estates, IL, US - Received
- April 2, 1990
- Decision date
- June 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K973621 | Pre-View Cholangiography ClampGBZ · Traditional | Nashville Surgical Instruments | 12/17/1997SE |
| K944790 | Flexible Laparoscopic Cholangiography CatheterGBZ · Traditional | Applied Medical Resources | 11/29/1994SE |
| K942450 | EndopathGBZ · Traditional | Ethicon Endo-Surgery, Inc. | 08/05/1994SE |
| K932228 | Microvasive Insurg Chloangiographic CatheterGBZ · Traditional | Boston Scientific Corp | 08/10/1993SE |
| K926217 | Terumo Angiographic Catheter for Laporoscopic UseGBZ · Traditional | Terumo Medical Corp. | 07/13/1993SE |
| K926143 | Angiolapcath Cholangiography KitGBZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/07/1993SESK |
| K924212 | Stryker Endoscopy Cholangiogram KitGBZ · Traditional | Stryker Corp. | 07/07/1993SESK |
| K925742 | Clarus Cholangiogram Catheter KitGBZ · Traditional | Clarus Medical Systems, Inc. | 06/01/1993SESK |
| K924981 | Operative Cholangiogram CatheterGBZ · Traditional | Taut, Inc. | 04/06/1993SE |
| K924480 | Cholangiography ClampGBZ · Traditional | Applied Medical Resources | 03/03/1993SE |
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| K894106 | Drake Willock Reverse Osmosis Water Treatment SystFIP · Traditional | 11/08/1989SE |
| K884353 | Ultrx(Tm) 850 Artificial KidneyKDI · Traditional | 12/08/1988SE |
| K880459 | 480 High-Flow Ultrafiltration Control DialysateFKP · Traditional | 04/13/1988SE |
| K873279 | 8810 Pump-Pump Single Needle DeviceFIF · Traditional | 10/23/1987SE |
| K864784 | Seraflo(Tm) Bloodlines for HemodialysisFJK · Traditional | 01/20/1987SE |
| K862304 | Drake Willock Central Dialysate Delivery SystemFKQ · Traditional | 09/09/1986SE |
| K853513 | Drake Willock 480 Uf Control Idalysate Delivery SyFKP · Traditional | 11/06/1985SE |
| K844185 | Modified C-DakKOC · Traditional | 01/03/1985SE |
Questions and answers
When was Wurtz Choley Clip (TM) cleared by the FDA?
Wurtz Choley Clip (TM) (K901520) received a 510(k) decision of Substantially Equivalent on June 26, 1990, 85 days after the submission was received.
What is the product code of K901520?
The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.