Flexible Tip Aspirating Tubes
FDA 510(k) K761079 · Pilling Co.
510(k) numberK761079
Submission
- Device name
- Flexible Tip Aspirating Tubes
- Applicant
- Pilling Co.
Mchenry, IL, US - Received
- November 19, 1976
- Decision date
- December 9, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | Wiltek Medical, Inc. | 02/15/1994SE |
| 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 |
More from Parexel Intl. Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K002582 | Pilling E-Frazier Bipolar Suction TubeGEI · Traditional | 11/03/2000SE |
| K934427 | Pilling Laparoscopic InstrumentationGEI · Traditional | 01/10/1994SE |
| K925370 | Triangular Jaw Microlaryngeal ForcepsELW · Traditional | 03/18/1993SE |
| K925198 | Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional | 02/12/1993SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | 09/23/1992SE |
| K914015 | Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional | 11/21/1991SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | 06/25/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | 03/01/1991SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
Questions and answers
When was Flexible Tip Aspirating Tubes cleared by the FDA?
Flexible Tip Aspirating Tubes (K761079) received a 510(k) decision of Substantially Equivalent on December 9, 1976, 20 days after the submission was received.
What is the product code of K761079?
The FDA product code is BYY – Tube, Aspirating, Flexible, Connecting, a Class II (moderate risk) device regulated under 21 CFR 880.6740.