FDA 510(k) clearance · back to tracker

cCeLL - In vivo

VPIX Medical, Inc. cleared K260315 on 2026-10-16, decision: substantially equivalent

K-number

K260315

Sponsor

VPIX Medical, Inc.

Device

cCeLL - In vivo

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-16

Product code

GWG

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.1480

Official FDA record

Open K260315on 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 K260315 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.