Wiltek Irrigaiton/Aspiration Tube Set
FDA 510(k) K922989 · Wiltek Medical, Inc.
510(k) numberK922989
Submission
- Device name
- Wiltek Irrigaiton/Aspiration Tube Set
- Applicant
- Wiltek Medical, Inc.
Winston-Salem, NC, US - Received
- June 22, 1992
- Decision date
- February 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYY – Tube, Aspirating, Flexible, Connecting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960616 | Vitaflow Suction/Aspiration Tubing SetBYY · Traditional | Vital Concepts, Inc. | 05/06/1996SE |
| K960218 | Connecting TubingBYY · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K955151 | Maxi-Flow Suction Tube/Top Gun Suction IrrigatorBYY · Traditional | Bio-Medical Devices, Inc. | 01/24/1996SE |
| K955149 | Maxi-Flow Suction Handle/The Reel Thing Tubing ReelBYY · Traditional | Bio-Medical Devices, Inc. | 01/24/1996SE |
| K955150 | Maxi-FlowBYY · Traditional | Bio-Medical Devices, Inc. | 01/23/1996SE |
| K911586 | General Hospital Tubing Clamp (Non-Electric)BYY · Traditional | Megadyne Medical Products, Inc. | 07/02/1991SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | Acacia Laboratories, Inc. | 05/07/1990SE |
| K873463 | Van Dellen Aspirating TubingBYY · Traditional | Van Dellen, Ltd. | 11/23/1987SE |
| K853296 | Emodren Guide Needle for Drainage Tube & EmodrenBYY · Traditional | Parexel Intl. Corp. | 08/15/1985SE |
| K843470 | Pharma-Plast Connecting Tube Type Suct-BYY · Traditional | Zimmar Consulting , Ltd. | 11/16/1984SE |
More from Zimmar Consulting , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K990231 | Wiltek Hot Biopsy ForcepsKGE · Traditional | 04/13/1999SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | 06/01/1993SE |
| K914882 | Wiltek Balloon Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914881 | Wiltek Laparoscopic Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914132 | Wiltek Electrocautery Active CordGEI · Traditional | 09/25/1991SE |
| K914131 | Wiltek Electrocautery AdaptorGEI · Traditional | 09/25/1991SE |
| K912288 | Wiltek Standard Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K912122 | Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K910334 | Electrocautery ProbeGEI · Traditional | 02/21/1991SE |
| K894871 | Wiltek Biliary Stent SetFGE · Traditional | 12/21/1989SE |
Questions and answers
When was Wiltek Irrigaiton/Aspiration Tube Set cleared by the FDA?
Wiltek Irrigaiton/Aspiration Tube Set (K922989) received a 510(k) decision of Substantially Equivalent on February 15, 1994, 603 days after the submission was received.
What is the product code of K922989?
The FDA product code is BYY – Tube, Aspirating, Flexible, Connecting, a Class II (moderate risk) device regulated under 21 CFR 880.6740.