DEMETECH POLYESTER NONABSORBABLE SUTURE— 510(k) K023030
Substantially EquivalentDemetech Corp.
FDA 510(k) clearance K023030 for DEMETECH POLYESTER NONABSORBABLE SUTURE, Substantially Equivalent on 2003-06-18. Applicant: Demetech Corp.. Device class: 2.
Clearance details
- Applicant
- Demetech Corp.
- 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
- Miami, FL, US
Recent devices under product code GAT
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view all- K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
- K123940 — DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
- K130083 — DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
- K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
- K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
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.