InjecSURE Injection System
Carbon Medical Technologies, Inc. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- St. Paul
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 1290 Hammond Rd.
- Statement or summary
- Summary
- Product code
- FBK
- Zip code
- 55110
- Applicant
- Carbon Medical Technologies, Inc.
- Decision date
- 2026-03-31
- Decision code
- SESE
- Country code
- US
- Device name
- InjecSURE Injection System
- Advisory committee
- GU
- Contact
- Jared Klein
- K number
- K253598
- State
- MN
- Date received
- 2025-11-18
- Review advisory committee
- GU
- Postal code
- 55110
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3002647932, 3012042439, 3010288205, 1222168, 3014620201, 1519132, 3007156625, 1061927, 3005099803, 3011193403, 3041276591, 1018233, 3021632375, 3006750742, 1643817, 3010707607, 1056129, 9610617, 3010273872, 3009747810, 3015142721, 3017390965, 3017178358, 3013526170, 3013440400, 3003814961, 3007695959, 3011146996, 3007699067, 8010047, 3027454635, 3005941719, 3008274780, 3035434483, 3046205723, 3021023752, 1528319, 3015042209, 9610614, 3004784537 +59 more
- FEI number
- 3002647932, 3002995060, 3012042439, 3010288205, 1222168, 3014620201, 1519132, 3005099803, 3011193403, 3041276591, 1018233, 3021632375, 3006750742, 1643817, 3010707607, 3010273872, 3007475226, 3009747810, 3015142721, 3017390965, 3017178358, 3013526170, 3013440400, 3003814961, 3007695959, 3002806565, 3011146996, 3007699067, 1000306139, 3027454635, 3008274780, 3035434483, 3046205723, 3021023752, 3015042209, 3004784537, 1220592, 3002807111, 3011050570, 3002807917 +59 more