VitroPRO
by Civco Medical Instruments Co., Inc. 2 variants
510(k) K231783
VitroPRO is a medical device (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Civco Medical Instruments Co., Inc., cleared under FDA 510(k) K231783 on 14 Nov 2023, 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 | NumberK231783 | Date14 Nov 2023 | StatusActive |
Official records
- FDA 510(k) database K231783
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITX
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K231783
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 | |||
|---|---|---|---|---|
| Needle Guide 667-187 | 667-187 / 667-187 | 10841436122655 | — | On the market |
| Needle Guide 667-188 | 667-188, 667-188-5 / 667-188 | 10841436122662 | — | On the market |
| Needle Guide 810-400 | 810-400, 810-400-5 / 810-400 | 10841436123225 | — | On the market |
| Needle Guide 810-401 | 810-401, 810-401-5 / 810-401 | 10841436123249 | — | On the market |
| Needle Guide 842-001 | 842-001, 842-001-5 / 842-001 | 10841436122211 | — | On the market |
| Needle Guide 842-002 | 842-002, 842-002-5 / 842-002 | 10841436122228 | — | On the market |
| Needle Guide 842-004 | 842-004, 842-004-5 / 842-004 | 10841436122242 | — | On the market |
| Needle Guide 842-009 | 842-009, 842-009-5 / 842-009 | 10841436125953 | — | On the market |
| Needle Guide 844-001 | 844-001, 844-001-5 / 844-001 | 10841436122266 | — | On the market |
| Needle Guide 857-001 | 857-001, 857-001-5 / 857-001 | 10841436122273 | — | On the market |
| Needle Guide 857-004 | 857-004, 857-004-5 / 857-004 | 10841436125939 | — | On the market |
| Needle Guide 867-001 | 867-001, 867-001-5 / 867-001 | 10841436122297 | — | On the market |
| Needle Guide 867-003 | 867-003, 867-003-5 / 867-003 | 10841436122310 | — | On the market |
| Needle Guide 867-005 | 867-005, 867-005-5 / 867-005 | 10841436122334 | — | On the market |
| Needle Guide 867-010 | 867-010, 867-010-5 / 867-010 | 10841436125915 | — | On the market |
| Needle Guide 876-001 | 876-001, 867-001-5 / 876-001 | 10841436122358 | — | On the market |
| Needle Guide 880-001 | 880-001, 880-001-5 / 880-001 | 10841436122365 | — | On the market |
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