TruDi NAV Suction Instruments— 510(k) K180948
Substantially EquivalentAcclarent, Inc.
FDA 510(k) clearance K180948 for TruDi NAV Suction Instruments, Substantially Equivalent on 2018-07-20. Applicant: Acclarent, Inc.. Device class: 2.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Code PGW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Recent devices under product code PGW
view allMore clearances from Acclarent, Inc.
view allAdverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
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 K180948
K-number listed on FDA's recall record- Z-2507-2024 — TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
- Z-0415-2022 — TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
- Z-0824-2020 — TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
- Z-0825-2020 — TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
- Z-0826-2020 — TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180948.
Data sourced from openFDA. This site is unofficial and independent of the FDA.