CONMED LINVATEC 300W XENON LIGHT SOURCE— 510(k) K070376
Substantially EquivalentConmed Linvatec
FDA 510(k) clearance K070376 for CONMED LINVATEC 300W XENON LIGHT SOURCE, Substantially Equivalent on 2007-08-20. Applicant: Conmed Linvatec. Device class: 2.
Clearance details
- Applicant
- Conmed Linvatec
- Product code
- Code GCT
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
Recent devices under product code GCT
view allMore clearances from Conmed Linvatec
view all- K111779 — Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
- K102410 — MATRYX INTERFERENCE SCREW (5.0-6.5MM)
- K102339 — CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
- K101100 — CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
- K092898 — CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
Adverse events under product code GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
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 K070376
K-number listed on FDA's recall record- Z-2455-2012 — ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
- Z-2456-2012 — ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070376.
Data sourced from openFDA. This site is unofficial and independent of the FDA.