Renova RP Centesis Pump
FDA 510(k) K221042 · Gi Supply, Inc.
510(k) numberK221042
Submission
- Device name
- Renova RP Centesis Pump
- Applicant
- Gi Supply, Inc.
Mechanicsburg, PA, US - Received
- April 8, 2022
- Decision date
- April 19, 2023
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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| 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 |
|---|---|---|
| K202376 | EverLift Submucosal Lifting AgentPLL · Special | 09/30/2020SE |
| K191923 | EverLift Submucosal Lifting AgentPLL · Traditional | 06/20/2020SE |
| K031360 | Gi Supply Biliary StentFGE · Traditional | 09/24/2003SE |
| K012411 | Hp-OneLYR · Traditional | 09/25/2001SE |
| K970187 | Runyon Large Volume Paracentesis KitLRO · Traditional | 02/14/1997SE |
| K970186 | Gi Supply Paracentesis PumpBTA · Traditional | 02/14/1997SE |
| K944903 | Hp-FastLYR · Traditional | 04/20/1995SE |
| K931044 | Oxy-BlocMNK · Traditional | 10/04/1993SE |
| K915816 | Bite Block/Mouthpiece for EndoscopyEOQ · Traditional | 03/27/1992SE |
Questions and answers
When was Renova RP Centesis Pump cleared by the FDA?
Renova RP Centesis Pump (K221042) received a 510(k) decision of Substantially Equivalent on April 19, 2023, 376 days after the submission was received.
What is the product code of K221042?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.