Entree Needle
FDA 510(k) K914426 · Core Dynamics, Inc.
510(k) numberK914426
Submission
- Device name
- Entree Needle
- Applicant
- Core Dynamics, Inc.
Jacksonville, FL, US - Received
- October 2, 1991
- Decision date
- November 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FHO – Pneumoperitoneum Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
For establishment of a pneumoperitoneum in abdomen.
Other 510(k)s with product code FHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172120 | Veress NeedleFHO · Traditional | Wickimed (Huizhou) Medical Equipment… | 09/14/2017SE |
| K121370 | Vectec Disposable Pneumoperitoneum NeedleFHO · Traditional | Vectec | 08/02/2013SE |
| K010779 | Modification To:Laparoscopic/Endoscopic InstrumentFHO · Special | Gibbons Surgical Corp. | 04/10/2001SE |
| K970788 | Pneumo-Matic Insufflation NeedleFHO · Traditional | Apple Medical Corp. | 03/27/1997SE |
| K960574 | Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional | Sherwood Medical Co. | 08/05/1996SE |
| K951894 | Access Expansion SystemFHO · Traditional | Micro-Medical Devices, Inc. | 06/15/1995SESK |
| K943624 | Elmed Pneumoperitoneum NeedlesFHO · Traditional | Henke-Sass, Wolf GmbH | 08/10/1994SE |
| K942484 | Verres NeedleFHO · Traditional | Linvatec Corp. | 06/24/1994SE |
| K930474 | Needle, Pneumoperitoneum, Spring LoadedFHO · Traditional | Ranfac, Corp. | 07/23/1993SE |
| K915725 | Clarus Models 1230 and 1231 Laparo-NeedleFHO · Traditional | Clarus Medical Systems, Inc. | 11/16/1992SE |
More from Clarus Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992250 | Core Audible Trocar IIGCJ · Traditional | 09/24/1999SE |
| K992190 | Core PouchGCJ · Traditional | 09/01/1999SE |
| K955490 | Laparoscopic KnitterGCJ · Traditional | 01/22/1996SE |
| K953903 | Laparoscopic Trocar Obturator, 5MM, 10/11MM, 10/12MMGCJ · Traditional | 10/20/1995SE |
| K953409 | Laparoscopic TrocarGCJ · Traditional | 10/16/1995SE |
| K950457 | Cannual and Trocar, SuperpubicHET · Traditional | 05/05/1995SE |
| K943172 | Core Dynamics' Laparoscopic Smoke EliminatorGCJ · Traditional | 07/28/1994SE |
| K935826 | Laparoscopic/Suction/Irrigation ProbeGCJ · Traditional | 05/18/1994SE |
| K932118 | Endoscopic Transmural Suture Needle SetHET · Traditional | 03/17/1994SE |
| K932021 | Entree Cannula Fascia AnchorsFBM · Traditional | 01/11/1994SE |
Questions and answers
When was Entree Needle cleared by the FDA?
Entree Needle (K914426) received a 510(k) decision of Substantially Equivalent on November 27, 1991, 56 days after the submission was received.
What is the product code of K914426?
The FDA product code is FHO – Pneumoperitoneum Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1500.