Surgimedics, SLP Laparoscopic Cholangiogram Cath
FDA 510(k) K903709 · Lifestream Int'L, Inc.
510(k) numberK903709
Submission
- Device name
- Surgimedics, SLP Laparoscopic Cholangiogram Cath
- Applicant
- Lifestream Int'L, Inc.
The Woodlands, TX, US - Received
- August 16, 1990
- Decision date
- October 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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| K964571 | Vision Cardioplegia Delivery SystemDTR · Traditional | 08/08/1997SE |
| K962354 | Diomed 15, 30, 60 Surgical Diode LaserGEX · Traditional | 09/11/1996SE |
| K920178 | Cardiotomy Reservoir W/20 Micron FiliterDTN · Traditional | 05/13/1993SE |
| K920618 | Autotransfusion Suction SetCAC · Traditional | 03/12/1993SE |
| K913181 | Autologous Blood Processing SystemCAC · Traditional | 05/20/1992SE |
| K914396 | Surgi Light Non-Contact FibersGEX · Traditional | 12/23/1991SE |
| K912045 | TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional | 10/31/1991SE |
| K911523 | Modification to Model 90-1460 Laser AdapterGEX · Traditional | 04/22/1991SE |
| K910726 | Light-Touch and Surgi Light FibersGEX · Traditional | 03/29/1991SE |
| K904491 | TMP Left Atrial Pressure Cath Cat.# 100-00X-000DQO · Traditional | 02/01/1991SE |
Questions and answers
When was Surgimedics, SLP Laparoscopic Cholangiogram Cath cleared by the FDA?
Surgimedics, SLP Laparoscopic Cholangiogram Cath (K903709) received a 510(k) decision of Substantially Equivalent on October 26, 1990, 71 days after the submission was received.
What is the product code of K903709?
The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.