INSIGHT, MODEL S980000
FDA 510(k) clearance K012232 · decided 2002-06-07
Clearance details
- K-number
- K012232
- Device name
- INSIGHT, MODEL S980000
- Applicant
- Sandhill Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-16
- Decision date
- 2002-06-07
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sandhill Scientific
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (K252605) | Medspira, LLC | 2025-12-05 |
| Solar Compact (G4-1) (K240007) | Laborie Medical Technologies, Corp. | 2024-05-06 |
| EndoflipTM 300 System (K231861) | Covidien, LLC | 2023-07-21 |
| EndoflipTM 300 (K223705) | Covidien, LLC | 2023-04-14 |
| Transit-Pellets (K222000) | Medifactia AB | 2023-01-18 |
| IntraMarX 3D Radiopaque Marker (K201106) | Anx Robotica Corp | 2020-05-21 |
| IntraMarX Radiopaque Markers (K191087) | Anx Robotica Corp | 2019-12-18 |
| Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) | Diversatek Healthcare | 2019-10-03 |
| Transit-Pellets (K181760) | Medifactia AB | 2019-08-08 |
| EndoFLIP System (K183072) | Crospon, Ltd. | 2019-02-15 |
| SITZMARKS (K181750) | Konsyl Pharmaceuticals | 2018-11-15 |
| EndoFLIP® System with FLIP Topography module (K170833) | Crospon, Ltd. | 2017-04-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ZVU Functional GI Software, REF: ZVU-3 recall (Z-2521-2023) | Diversatek Healthcare | 2023-09-07 |
| Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use b recall (Z-1487-2012) | Sandhill Scientific, Inc | 2012-05-07 |