VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD— 510(k) K041669
Substantially EquivalentSynovis Surgical Innovations
FDA 510(k) clearance K041669 for VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD, Substantially Equivalent on 2004-10-27. Applicant: Synovis Surgical Innovations. Device class: 2.
Clearance details
- Applicant
- Synovis Surgical Innovations
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FTM
view allMore clearances from Synovis Surgical Innovations
view all- K122306 — SYNOVIS COLLAGEN MATRIX (TBD)
- K083039 — VERITAS COLLAGEN MATRIX (DRY)
- K062915 — VERITAS COLLAGEN MATRIX
- K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
- K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.