SPOT ENDOSCOPIC MARKER
FDA 510(k) clearance K993951 · decided 2000-02-18
Clearance details
- K-number
- K993951
- Device name
- SPOT ENDOSCOPIC MARKER
- Applicant
- Chek-Med Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-11-22
- Decision date
- 2000-02-18
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- NBG
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Willington, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOMARK STERILE INDIA INK (K042901) | Pmt Corp. | 2005-03-16 |
Recalls involving this device
No recalls on record reference this clearance.