LOFRIC PRIMO, LOFRIC HYDRO-KIT— 510(k) K122078
Substantially EquivalentAstra Tech, Inc.
FDA 510(k) clearance K122078 for LOFRIC PRIMO, LOFRIC HYDRO-KIT, Substantially Equivalent on 2012-10-31. Applicant: Astra Tech, Inc.. Device class: 2.
Clearance details
- Applicant
- Astra Tech, Inc.
- Product code
- Code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code EZD
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view all- K120338 — ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
- K113003 — ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
- K112138 — ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
- K110356 — ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
- K110640 — ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
Adverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
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 →
Recalls naming K122078
K-number listed on FDA's recall record- Z-2643-2020 — LoFric Origo, Nelaton, 16in, FR10 urinary catheters
- Z-2644-2020 — LoFric Origo, Tiemann, 16in, FR12 urinary catheters
- Z-2645-2020 — LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122078.
Data sourced from openFDA. This site is unofficial and independent of the FDA.