URETHRAL AND URETERAL BALLOON DILATATORS— 510(k) K884711
Substantially EquivalentPrimrose Medical, Inc.
FDA 510(k) clearance K884711 for URETHRAL AND URETERAL BALLOON DILATATORS, Substantially Equivalent on 1989-09-29. Applicant: Primrose Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Primrose Medical, Inc.
- Product code
- Code EZN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5470
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
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More clearances from Primrose Medical, Inc.
view allAdverse events under product code EZN
product code EZN- Death
- 3
- Injury
- 127
- Total
- 130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.