Pre-View Cholangiography Clamp
FDA 510(k) K973621 · Nashville Surgical Instruments
510(k) numberK973621
Submission
- Device name
- Pre-View Cholangiography Clamp
- Applicant
- Nashville Surgical Instruments
Springfield, TN, US - Received
- September 23, 1997
- Decision date
- December 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K924128 | Cholangiography CatheterGBZ · Traditional | Applied Medical Resources | 02/10/1993SE |
More from Applied Medical Resources
| 510(k) | Device | Decision |
|---|---|---|
| K081366 | Kumar T-Anchors Hernia SetGAR · Traditional | 07/15/2008SE |
Questions and answers
When was Pre-View Cholangiography Clamp cleared by the FDA?
Pre-View Cholangiography Clamp (K973621) received a 510(k) decision of Substantially Equivalent on December 17, 1997, 85 days after the submission was received.
What is the product code of K973621?
The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.