DEMETECH NYLON NONABSORBABLE SUTURE— 510(k) K023028
Substantially EquivalentDemetech Corp.
FDA 510(k) clearance K023028 for DEMETECH NYLON NONABSORBABLE SUTURE, Substantially Equivalent on 2003-06-18. Applicant: Demetech Corp.. Device class: 2.
Clearance details
- Applicant
- Demetech Corp.
- Product code
- Code GAR
- Device class
- Class 2
- Regulation
- 21 CFR 878.5020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code GAR
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- K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
- K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
Adverse events under product code GAR
product code GAR- Injury
- 422
- Malfunction
- 3,386
- Other
- 4
- Total
- 3,812
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.