CHROMOPHARE F 628 AND F 528— 510(k) K120392
Substantially EquivalentBerchtold GmbH & Co. KG
FDA 510(k) clearance K120392 for CHROMOPHARE F 628 AND F 528, Substantially Equivalent on 2012-02-16. Applicant: Berchtold GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Berchtold 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
- Tuttlingen, DE
Recent devices under product code FSY
view allMore clearances from Berchtold 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 K120392
K-number listed on FDA's recall record- Z-1688-2026 — Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
- Z-1506-2024 — Chromophare Surgical Light System , REF CH00000001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120392.
Data sourced from openFDA. This site is unofficial and independent of the FDA.