Laparoscopic Trocar
FDA 510(k) K953409 · Core Dynamics, Inc.
510(k) numberK953409
Submission
- Device name
- Laparoscopic Trocar
- Applicant
- Core Dynamics, Inc.
Jacksonville, FL, US - Received
- July 20, 1995
- Decision date
- October 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from TroCare, LLC
| 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 |
| 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 |
| K932020 | Entree Blunt Tip Trocar and AdapterHET · Traditional | 01/11/1994SE |
Questions and answers
When was Laparoscopic Trocar cleared by the FDA?
Laparoscopic Trocar (K953409) received a 510(k) decision of Substantially Equivalent on October 16, 1995, 88 days after the submission was received.
What is the product code of K953409?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.