Bile Endoprosthesis Set
FDA 510(k) K860534 · Angiomed U.S., Inc.
510(k) numberK860534
Submission
- Device name
- Bile Endoprosthesis Set
- Applicant
- Angiomed U.S., Inc.
Anaheim, CA, US - Received
- February 12, 1986
- Decision date
- March 10, 1986
- 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 |
More from Applied Medical Resources
| 510(k) | Device | Decision |
|---|---|---|
| K874771 | Angiomed Introducing SetsDWB · Traditional | 01/12/1988SE |
| K874585 | Angiomed Osty-Cut Bone Biopsy NeedleDWO · Traditional | 12/02/1987SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | 01/30/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | 10/24/1986SE |
| K862805 | Angiomed Vac-U-Cut Biopsy NeedleGDM · Traditional | 09/29/1986SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | 09/23/1986SE |
| K854910 | AngioflowDQO · Traditional | 07/17/1986SE |
| K854912 | Angiomed Guied WiresDQX · Traditional | 04/16/1986SE |
| K854908 | UroflexFAD · Traditional | 03/14/1986SE |
| K855143 | Angiomed Exchange Drainage Catheter SetsKOD · Traditional | 03/11/1986SE |
Questions and answers
When was Bile Endoprosthesis Set cleared by the FDA?
Bile Endoprosthesis Set (K860534) received a 510(k) decision of Substantially Equivalent on March 10, 1986, 26 days after the submission was received.
What is the product code of K860534?
The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.