NEWMAN CANNULAE SYSTEM (NCS)— 510(k) K862936
Substantially Equivalent for Some IndicationsByron Medical
FDA 510(k) clearance K862936 for NEWMAN CANNULAE SYSTEM (NCS), Substantially Equivalent for Some Indications on 1986-08-14. Applicant: Byron Medical. Device class: 1.
Clearance details
- Applicant
- Byron Medical
- Product code
- Code GEA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code GEA
view allMore clearances from Byron Medical
view all- K040149 — PSI-TEC PERISTALTIC INFILTRATION PUMP
- K001803 — ACCELERATOR RECIPROCATING CANNULA
- K981215 — PSI-TEC LIPOSUCTION ASPIRATOR
- K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
- K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
Adverse events under product code GEA
product code GEA- Malfunction
- 587
- Total
- 587
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.