FDA 510(k) clearance · back to tracker
epi-ConneKt Wound Matrix
MLM Biologics, Inc. cleared K260530 on 2026-10-15, decision: substantially equivalent
K-number
K260530
Sponsor
MLM Biologics, Inc.
Device
epi-ConneKt Wound Matrix
Class
Class U
Decision
Substantially Equivalent
Decision date
2026-10-15
Product code
KGN
Advisory committee
Unknown
Medical specialty
Unknown
Regulation number
-
Official FDA record
Open K260530on 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 K260530 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 sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.