ACCUPLACE (TM)— 510(k) K904172
Substantially EquivalentDlp, Inc.
FDA 510(k) clearance K904172 for ACCUPLACE (TM), Substantially Equivalent on 1990-11-21. Applicant: Dlp, Inc.. Device class: 1.
Clearance details
- Applicant
- Dlp, Inc.
- Product code
- Code GDF
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Rapids, MI, US
Recent devices under product code GDF
view allMore clearances from Dlp, Inc.
view allRecalls naming K904172
K-number listed on FDA's recall record- Z-1037-2016 — (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
- Z-1038-2016 — (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
- Z-1039-2016 — 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
- Z-1040-2016 — 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904172.
Data sourced from openFDA. This site is unofficial and independent of the FDA.