STEERABLE STYLET— 510(k) K040001
Substantially EquivalentSynovis Surgical Innovations
FDA 510(k) clearance K040001 for STEERABLE STYLET, Substantially Equivalent on 2004-03-09. Applicant: Synovis Surgical Innovations. Device class: 2.
Clearance details
- Applicant
- Synovis Surgical Innovations
- Product code
- Code DRB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code DRB
view allMore clearances from Synovis Surgical Innovations
view all- K122306 — SYNOVIS COLLAGEN MATRIX (TBD)
- K083039 — VERITAS COLLAGEN MATRIX (DRY)
- K062915 — VERITAS COLLAGEN MATRIX
- K041669 — VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
- K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
Adverse events under product code DRB
product code DRB- Death
- 36
- Injury
- 562
- Total
- 598
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.