Clement-Pilling Cholangiography Cath Guide/Clamp
FDA 510(k) K914015 · Pilling Co.
510(k) numberK914015
Submission
- Device name
- Clement-Pilling Cholangiography Cath Guide/Clamp
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- September 9, 1991
- Decision date
- November 21, 1991
- 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 |
| 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 |
|---|---|---|
| K002582 | Pilling E-Frazier Bipolar Suction TubeGEI · Traditional | 11/03/2000SE |
| K934427 | Pilling Laparoscopic InstrumentationGEI · Traditional | 01/10/1994SE |
| K925370 | Triangular Jaw Microlaryngeal ForcepsELW · Traditional | 03/18/1993SE |
| K925198 | Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional | 02/12/1993SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | 09/23/1992SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | 06/25/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | 03/01/1991SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
| K882930 | Laser Laryngoscope Dedo Articula. & Feder Dedo ExCCW · Traditional | 08/16/1988SE |
Questions and answers
When was Clement-Pilling Cholangiography Cath Guide/Clamp cleared by the FDA?
Clement-Pilling Cholangiography Cath Guide/Clamp (K914015) received a 510(k) decision of Substantially Equivalent on November 21, 1991, 73 days after the submission was received.
What is the product code of K914015?
The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.