SAPIMED DISPOSABLE SIGMOIDOSCOPE— 510(k) K070915
Substantially EquivalentSapimed S.P.A.
FDA 510(k) clearance K070915 for SAPIMED DISPOSABLE SIGMOIDOSCOPE, Substantially Equivalent on 2007-07-06. Applicant: Sapimed S.P.A.. Device class: 2.
Clearance details
- Applicant
- Sapimed S.P.A.
- Product code
- Code KDM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
More clearances from Sapimed S.P.A.
view allRecalls naming K070915
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070915.
Data sourced from openFDA. This site is unofficial and independent of the FDA.