Nouvag AG - Vacuson 40 and Vacuson 60
FDA 510(k) K042943 · Nouvag AG
510(k) numberK042943
Submission
- Device name
- Nouvag AG - Vacuson 40 and Vacuson 60
- Applicant
- Nouvag AG
Gebenstorf, CH - Received
- October 25, 2004
- Decision date
- December 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BTA
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|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/15/2026SE |
| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 05/12/2026SE |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional | Shenzhen Dongjiang Technology Co., Ltd. | 04/14/2026SE |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 03/13/2026SE |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special | Shenzhen Desida Technology Co., Ltd. | 06/06/2025SE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
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| K042822 | TCM Endo V, Model 1534EKX · Traditional | 12/22/2004SE |
| K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55DZI · Traditional | 11/03/2004SE |
| K022505 | Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063…EGS · Traditional | 10/01/2003SE |
| K013185 | TCM Endo IIIEFA · Traditional | 11/28/2001SE |
| K000710 | MD 10, Sem, SM 12, CBMEFB · Traditional | 05/11/2000SE |
| K981679 | TCM 3000 and TCM EndoEFB · Traditional | 02/09/1999SE |
Questions and answers
When was Nouvag AG - Vacuson 40 and Vacuson 60 cleared by the FDA?
Nouvag AG - Vacuson 40 and Vacuson 60 (K042943) received a 510(k) decision of Substantially Equivalent on December 17, 2004, 53 days after the submission was received.
What is the product code of K042943?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.