F1 DIODE LASER SYSTEM— 510(k) K004021
Substantially EquivalentOpus Medical, Inc.
FDA 510(k) clearance K004021 for F1 DIODE LASER SYSTEM, Substantially Equivalent on 2001-03-27. Applicant: Opus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Opus Medical, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Albuquerque,, NM, US
Recent devices under product code GEX
view allMore clearances from Opus Medical, Inc.
view all- K042584 — OPUS MINIMAGNUM ANCHOR WITH INSERTER
- K042914 — OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
- K042031 — OPUS SPEEDSTITCH SUTURE DEVICE
- K041440 — OPUS MAGNUM ANCHOR WITH INSERTER
- K033317 — SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.