TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001— 510(k) K011693
Substantially EquivalentTrumpf Medical Systems, Inc.
FDA 510(k) clearance K011693 for TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001, Substantially Equivalent on 2001-06-13. Applicant: Trumpf Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Trumpf Medical Systems, Inc.
- 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
- Charleston, SC, US
Recent devices under product code FSY
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 K011693
K-number listed on FDA's recall record- Z-2355-2015 — Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. 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-0484-2014 — Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
- Z-0077-2013 — Helion and Xenion surgical lights, 501/01 series KLM lights. The 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 K011693.
Data sourced from openFDA. This site is unofficial and independent of the FDA.