Operative Cholangiogram Catheter
FDA 510(k) K924981 · Taut, Inc.
510(k) numberK924981
Submission
- Device name
- Operative Cholangiogram Catheter
- Applicant
- Taut, Inc.
Geneva, IL, US - Received
- October 1, 1992
- Decision date
- April 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K924480 | Cholangiography ClampGBZ · Traditional | Applied Medical Resources | 03/03/1993SE |
| K924128 | Cholangiography CatheterGBZ · Traditional | Applied Medical Resources | 02/10/1993SE |
More from Applied Medical Resources
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|---|---|---|
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| K021731 | Adapt Open Access Port, Model 41233GCJ · Traditional | 08/08/2002SE |
| K011018 | Taut Balloon Catheter, Model 50640GCA · Traditional | 06/22/2001SE |
| K010007 | Adapt Laparoscopic Port & Adapt Reducer CapGCJ · Traditional | 02/22/2001SE |
| K003703 | Taut-Insufflation NeedleHIF · Traditional | 02/22/2001SE |
| K992907 | IntraducerGBW · Traditional | 10/05/1999SE |
| K992904 | Mini-PortGBW · Traditional | 10/05/1999SE |
| K972112 | Intraducer Port SC CATALOG#31275,31035,30915, and 31450GBW · Traditional | 12/01/1997SE |
| K962003 | Tuat Splatter Control Shield SCS-300KKX · Traditional | 07/18/1996SE |
| K960883 | Intraducer Peritoneal Catheter 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8GCJ · Traditional | 03/20/1996SE |
Questions and answers
When was Operative Cholangiogram Catheter cleared by the FDA?
Operative Cholangiogram Catheter (K924981) received a 510(k) decision of Substantially Equivalent on April 6, 1993, 187 days after the submission was received.
What is the product code of K924981?
The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.