TELA Bio: receives FDA 510(k) clearance for Liora Monofilament Scaffold

What happened On Oct 5, 2026, TELA Bio, Inc. issued a press release announcing that it has received U.S. Food and Drug Administration 510(k) clearance for its Liora Monofilament Scaffold product. A copy of the press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.

Key details

• Date of announcement: Oct 5, 2026.
• Product: Liora Monofilament Scaffold.
• Regulatory action: U.S. Food and Drug Administration 510(k) clearance.
• Supporting filing: press release filed as Exhibit 99.1.

Why it may matter This Form 8-K reports Item 8.01 (Other events), which covers other events the company announces outside of the standard items. A filing does not show why the insider traded or why the company acted.