AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP— 510(k) K140343

Name: FDA 510(k) clearance K140343
Creator: U.S. Food and Drug Administration
Published: 2014-05-13

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K140343 for AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP, Substantially Equivalent on 2014-05-13. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code MPN
Device class: Class 2
Regulation: 21 CFR 878.4010
Advisory panel: General, Plastic Surgery
Date received: 2014-02-11
Decision date: 2014-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MPN

view all

More clearances from Aesculap, Inc.

view all

K242762 — Aesculap Aicon® Series Container System2025-05-13
K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set2024-12-16
K223596 — SQ.line KERRISON2023-06-29
K214041 — Aesculap AICON Container2022-12-30
K211572 — Aesculap Slim Clip Applier2021-12-13

Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.