Gi Supply Paracentesis Pump
by Gi Supply
510(k) K970186
Gi Supply Paracentesis Pump is a medical device (FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by Gi Supply, cleared under FDA 510(k) K970186 on 14 Feb 1997, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970186 | Date14 Feb 1997 | StatusActive |
Official records
- FDA 510(k) database K970186
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BTA
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K970186
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| RenovaRP GIS-27 | GIS-27 / GIS-27 | 00893029002076 | — | On the market |
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