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The Tracker / October 2026 / K260315

510(k) cleared

cCeLL - In vivo

VPIX Medical, Inc. · Oct 16, 2026 · K260315

FDA cleared the cCeLL - In vivo from VPIX Medical, Inc. on Oct 16, 2026 under K260315, a traditional 510(k). The device falls under product code GWG, Endoscope, Neurological, regulated at 21 CFR 882.1480 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jan 30, 2026. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

VPIX Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K254030 (cCeLL405), K251852 (cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)).

Questions & Answers

What did FDA clear under K260315?

K260315 is the FDA 510(k) for cCeLL - In vivo, submitted by VPIX Medical, Inc.. FDA's decision date was Oct 16, 2026, under product code GWG (Endoscope, Neurological).

Who makes the cCeLL - In vivo?

VPIX Medical, Inc., based in Daejeon, is the applicant of record for K260315.

How long did the K260315 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Oct 16, 2026, 259 days later.

← All decisions in October 2026

Sources