ULTRACON ULTRAFILTRATOR— 510(k) K981253
Substantially EquivalentInterpore Intl.
FDA 510(k) clearance K981253 for ULTRACON ULTRAFILTRATOR, Substantially Equivalent on 1998-12-11. Applicant: Interpore Intl.. Device class: 2.
Clearance details
- Applicant
- Interpore Intl.
- Product code
- Code FJI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code FJI
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- K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
- K960945 — IMZ MEMBRANE TACK SYSTEM
- K960371 — INTERPORE THREADED IMPLANT
Adverse events under product code FJI
product code FJI- Death
- 2
- Total
- 2
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.