SECURLINE FRANSEENE NEEDLE— 510(k) K873369
Substantially EquivalentPrecision Dynamics Corp.
FDA 510(k) clearance K873369 for SECURLINE FRANSEENE NEEDLE, Substantially Equivalent on 1987-10-20. Applicant: Precision Dynamics Corp.. Device class: 2.
Clearance details
- Applicant
- Precision Dynamics Corp.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Van Nuys, CA, US
Recent devices under product code KNW
view allMore clearances from Precision Dynamics Corp.
view all- K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
- K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
- K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
- K990737 — 'ECURLINE UMBILICAL CORD CLAMP #3500
- K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.