Epix Irrigation Pump, Epix Suction Irrigation Tubing Set
FDA 510(k) K122619 · Applied Medical
510(k) numberK122619
Submission
- Device name
- Epix Irrigation Pump, Epix Suction Irrigation Tubing Set
- Applicant
- Applied Medical
Rancho Santa, CA, US - Received
- August 28, 2012
- Decision date
- October 2, 2012
- 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
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| 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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| K844726 | Gauze Sponge 4X4X12 PlyEFQ · Traditional | 04/01/1985SE |
| K844677 | Applied Gauze Sponge 2X2X12EFQ · Traditional | 04/01/1985SE |
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Questions and answers
When was Epix Irrigation Pump, Epix Suction Irrigation Tubing Set cleared by the FDA?
Epix Irrigation Pump, Epix Suction Irrigation Tubing Set (K122619) received a 510(k) decision of Substantially Equivalent on October 2, 2012, 35 days after the submission was received.
What is the product code of K122619?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.