TubeClear System
by Actuated Medical, Inc. 2 variants
510(k) K172556
TubeClear System is a Class II device made by Actuated Medical, Inc., cleared under FDA 510(k) K172556 on 29 Jun 2018, 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 | NumberK172556 | Date29 Jun 2018 | StatusActive |
Official records
- FDA 510(k) database K172556
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNT
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K172556
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 | |||
|---|---|---|---|---|
| TubeClear G-1008 | G-1008 | 00850458007089 | — | On the market |
| TubeClear G-1009 | G-1009 | 00850458007096 | — | On the market |
| TubeClear G-1010 | G-1010 | 00850458007102 | — | On the market |
| TubeClear G-1011 | G-1011 | 00850458007119 | — | On the market |
| TubeClear G-1012 | G-1012 | 00850458007126 | — | On the market |
| TubeClear G-1014 | G-1014 | 00850458007140 | — | On the market |
| TubeClear NE-1036 | NE-1036 | 00850458007362 | — | On the market |
| TubeClear NE-1042 | NE-1042 | 00850458007423 | — | On the market |
| TubeClear NE-1043 | NE-1043 | 00850458007430 | — | On the market |
| TubeClear NE-1045 | NE-1045 | 00850458007454 | — | On the market |
| TubeClear NE-1048 | NE-1048 | 00850458007485 | — | On the market |
| TubeClear NE-1050 | NE-1050 | 00850458007508 | — | On the market |
| TubeClear NE-1055 | NE-1055 | 00850458007553 | — | On the market |
| TubeClear TC-0608 | TC-0608 | 00850458007607 | — | On the market |
| TubeClear TC-0812 | TC-0812 | 00850458007614 | — | On the market |
| TubeClear TC-1018 | TC-1018 | 00850458007621 | — | On the market |
Similar devices
Other devices filed under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)).
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- Peel-Away G06447 PLVW-26.0-38 by COOK INCORPORATED
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- ELECATH(R) TRANSESOPHAGEAL PACING CATHETER by Electro-Catheter Corp.
- VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE by Norwich Eaton Pharmaceuticals, Inc.
- DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) by Dynarex Corp.
- GRAVITY ENTERAL FEEDING SET by Medical Connections
- Stylus by DEGANIA SILICONE LTD