Varidyne Model 250 Suction Drainage System
FDA 510(k) K883582 · Surgidyne, Inc.
510(k) numberK883582
Submission
- Device name
- Varidyne Model 250 Suction Drainage System
- Applicant
- Surgidyne, Inc.
Eden Prairie, MN, US - Received
- August 22, 1988
- Decision date
- October 3, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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| 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 |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K892334 | Leonard TubeKDH · Traditional | 05/31/1989SE |
| K864822 | Varidyne 550, Models 12E,12M,24E & 24M Suction SysBTC · Traditional | 01/15/1987SE |
| K860030 | Surgidyne Varidyne, Model 140-2I & Model 140-2IDBTA · Traditional | 02/12/1986SE |
| K852180 | Surgidynes Varidyne 350-2I & 350-2C Cordless Elec. · Traditional | 07/01/1985SN |
| K850634 | Surgidyne Surgiflo C.W.S. Drain ProductsGCY · Traditional | 06/28/1985SE |
Questions and answers
When was Varidyne Model 250 Suction Drainage System cleared by the FDA?
Varidyne Model 250 Suction Drainage System (K883582) received a 510(k) decision of Substantially Equivalent on October 3, 1988, 42 days after the submission was received.
What is the product code of K883582?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.