Vygon Cannula for Surgical Suction Yan Kauer 574/5
FDA 510(k) K851475 · Vygon Corp.
510(k) numberK851475
Submission
- Device name
- Vygon Cannula for Surgical Suction Yan Kauer 574/5
- Applicant
- Vygon Corp.
East Rutherford, NJ, US - Received
- April 15, 1985
- Decision date
- May 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
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Questions and answers
When was Vygon Cannula for Surgical Suction Yan Kauer 574/5 cleared by the FDA?
Vygon Cannula for Surgical Suction Yan Kauer 574/5 (K851475) received a 510(k) decision of Substantially Equivalent on May 3, 1985, 18 days after the submission was received.
What is the product code of K851475?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.