Question 1

Who is the manufacturer of Redermo Wound Matrix?

Accepted Answer

Beijing Kreate Medical Co., Ltd. filed the 510(k) submission for Redermo Wound Matrix (K260020).

Question 2

What is the FDA product code for Redermo Wound Matrix?

Accepted Answer

QSZ. as a Class U device in the SU panel.

Question 3

When was Redermo Wound Matrix cleared by the FDA?

Accepted Answer

Apr 16, 2026 (decision: SESE).

Question 4

What is the regulatory pathway for Redermo Wound Matrix?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like Redermo Wound Matrix?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K260020
Device Name	Redermo Wound Matrix
Applicant	Beijing Kreate Medical Co., Ltd.
Product Code	QSZ · SU
Decision Date	Apr 16, 2026
Decision	SESE
Submission Type	Traditional
Device Class	Class U

Redermo Wound Matrix

Device Facts

Regulatory Classification

Identification