OPUS SPEEDSTITCH SUTURE DEVICE— 510(k) K042031
Substantially EquivalentOpus Medical, Inc.
FDA 510(k) clearance K042031 for OPUS SPEEDSTITCH SUTURE DEVICE, Substantially Equivalent on 2004-10-19. Applicant: Opus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Opus Medical, Inc.
- Product code
- Code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
Recent devices under product code GAT
view allMore clearances from Opus Medical, Inc.
view all- K042584 — OPUS MINIMAGNUM ANCHOR WITH INSERTER
- K042914 — OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
- K041440 — OPUS MAGNUM ANCHOR WITH INSERTER
- K033317 — SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
- K030170 — REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
Adverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
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.