ILED— 510(k) K061317
Substantially EquivalentTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg
FDA 510(k) clearance K061317 for ILED, Substantially Equivalent on 2006-06-22. Applicant: Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg. Device class: 2.
Clearance details
- Applicant
- Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
- Product code
- Code FSY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munchen, DE
Recent devices under product code FSY
view allMore clearances from Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
view allAdverse events under product code FSY
product code FSY- Malfunction
- 2,759
- Other
- 1
- Total
- 2,760
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 K061317
K-number listed on FDA's recall record- Z-0563-2016 — Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
- Z-2353-2015 — Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Z-2354-2015 — Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Z-2356-2015 — Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Z-2357-2015 — Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Z-2311-2012 — Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061317.
Data sourced from openFDA. This site is unofficial and independent of the FDA.