Bifurcated Suction/Irrigat Tubing Set W/Push Butto
FDA 510(k) K926477 · Core Dynamics, Inc.
510(k) numberK926477
Submission
- Device name
- Bifurcated Suction/Irrigat Tubing Set W/Push Butto
- Applicant
- Core Dynamics, Inc.
Jacksonville, FL, US - Received
- December 29, 1992
- Decision date
- November 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBW – Catheter, Peritoneal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K942709 | Mediastinal Silicone DrainsGBW · Traditional | Sil-Med Corp. | 01/04/1996SN |
| K933510 | Argyle Turkel Safety Trocar Thoracic CatheterGBW · Traditional | Sherwood Medical Co. | 02/24/1994SE |
| K913733 | Sterile Chest TubeGBW · Traditional | Vascular Products, Inc. | 10/08/1991SE |
| K894220 | Houts Hysterectomy DrainGBW · Traditional | Helix Medical, Inc. | 08/24/1989SE |
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| 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 Bifurcated Suction/Irrigat Tubing Set W/Push Butto cleared by the FDA?
Bifurcated Suction/Irrigat Tubing Set W/Push Butto (K926477) received a 510(k) decision of Substantially Equivalent on November 12, 1993, 318 days after the submission was received.
What is the product code of K926477?
The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.