Entree Cannula Fascia Anchors
FDA 510(k) K932021 · Core Dynamics, Inc.
510(k) numberK932021
Submission
- Device name
- Entree Cannula Fascia Anchors
- Applicant
- Core Dynamics, Inc.
Jacksonville, FL, US - Received
- April 23, 1993
- Decision date
- January 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FBM – Cannula And Trocar, Suprapubic, Non-Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…FBM · Traditional | Snowden-Pencer | 03/12/1996SE |
| K911813 | Entree CannulaFBM · Traditional | Core Dynamics, Inc. | 07/19/1991SE |
| K900965 | GS-4550 Trocar Only, 11MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900964 | Cannula and Trocar, 11MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900963 | GS-4350 Trocar Only, 5.5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900962 | GS-4300 Cannula and Trocar, 5.5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900961 | GS-4100 Reducer Sleeve, 5MM to 3MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900955 | GS-4000 Reducer Sleeve, 11MM to 5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
More from Solos Endoscopy, 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 |
| K932020 | Entree Blunt Tip Trocar and AdapterHET · Traditional | 01/11/1994SE |
Questions and answers
When was Entree Cannula Fascia Anchors cleared by the FDA?
Entree Cannula Fascia Anchors (K932021) received a 510(k) decision of Substantially Equivalent on January 11, 1994, 263 days after the submission was received.
What is the product code of K932021?
The FDA product code is FBM – Cannula And Trocar, Suprapubic, Non-Disposable, a Class I (low risk) device regulated under 21 CFR 876.5090.