ENDOSCOPIC CATHETER
FDA 510(k) clearance K953967 · decided 1996-01-22
Clearance details
- K-number
- K953967
- Device name
- ENDOSCOPIC CATHETER
- Applicant
- Act Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-22
- Decision date
- 1996-01-22
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- ODD
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.