Bodai Swivel Y
FDA 510(k) K813324 · Sontek Industries, Inc.
510(k) numberK813324
Submission
- Device name
- Bodai Swivel Y
- Applicant
- Sontek Industries, Inc.
Mchenry, IL, US - Received
- November 24, 1981
- Decision date
- December 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSY – Catheters, Suction, Tracheobronchial
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6810
- Specialty
- Anesthesiology
Other 510(k)s with product code BSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031997 | Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction SystemBSY · Traditional | Mallinckrodt Dar S.R.L. | 11/25/2003SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | Ambu, Inc. | 10/25/1999SE |
| K982945 | Dual Purpose Closed CatheterBSY · Traditional | Spirit Medical Systems, Inc. | 09/22/1998SE |
| K981910 | Suction CatheterBSY · Traditional | Ni-Med, Inc. | 08/24/1998SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | Mallinckrodt Medical | 12/29/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | Amsino Intl., Inc. | 09/10/1997SE |
| K961707 | Trach-Eze Closed Ventilation Suction SystemBSY · Traditional | Sorenson Critical Care | 03/11/1997SE |
| K964369 | Trach Care Set with MicrobanBSY · Traditional | Ballard Medical Products | 02/11/1997SE |
| K960488 | Neo 2 Line Suction SystemBSY · Traditional | Alcove Medical, Inc. | 04/26/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | Sherwood Medical Co. | 03/28/1996SE |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K833374 | Bite-BlockJAY · Traditional | 11/03/1983SE |
| K833373 | Bodia Bronch-Saf Double SwivelBZA · Traditional | 11/03/1983SE |
| K833372 | Bodia Trach-Saf Double SwivelBZA · Traditional | 11/03/1983SE |
| K833361 | Tube-TitleJAY · Traditional | 11/03/1983SE |
| K812720 | Bodai Patient CommunicatorILQ · Traditional | 11/05/1981SE |
| K811241 | Bodai Suction -Safe 4BSY · Traditional | 05/27/1981SE |
Questions and answers
When was Bodai Swivel Y cleared by the FDA?
Bodai Swivel Y (K813324) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 35 days after the submission was received.
What is the product code of K813324?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.