FDA 510(k) clearance · back to tracker

INIVOX ELECTRODE/CATHETER SYS

Critikon Company, LLC cleared K832916 on 1983-11-14, decision: substantially equivalent

K-number

K832916

Sponsor

Critikon Company, LLC

Device

INIVOX ELECTRODE/CATHETER SYS

Class

Class III

Decision

Substantially Equivalent

Decision date

1983-11-14

Product code

LLE

Advisory committee

Unknown

Medical specialty

Unknown

Regulation number

Official FDA record

Open K832916on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K832916 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.