Endoscopic Transmural Suture Needle Set
FDA 510(k) K932118 · Core Dynamics, Inc.
510(k) numberK932118
Submission
- Device name
- Endoscopic Transmural Suture Needle Set
- Applicant
- Core Dynamics, Inc.
Jacksonville, FL, US - Received
- May 3, 1993
- Decision date
- March 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| 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 |
| 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 Endoscopic Transmural Suture Needle Set cleared by the FDA?
Endoscopic Transmural Suture Needle Set (K932118) received a 510(k) decision of Substantially Equivalent on March 17, 1994, 318 days after the submission was received.
What is the product code of K932118?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.