AbClose - Port Site Closure Device— 510(k) K160117

Name: FDA 510(k) clearance K160117
Creator: U.S. Food and Drug Administration
Published: 2016-09-09

Substantially Equivalent

Medeon Biodesign, Inc.

FDA 510(k) clearance K160117 for AbClose - Port Site Closure Device, Substantially Equivalent on 2016-09-09. Applicant: Medeon Biodesign, Inc.. Device class: 2.

Clearance details

Applicant: Medeon Biodesign, Inc.
Product code: Code OCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2016-01-19
Decision date: 2016-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCW

view all

K252400 — Endomina EZFuse system2026-02-13
K243750 — SimpleStitch Suturing System2025-04-17
K231240 — MaxTack Motorized Fixation Device2023-09-08
K213271 — MedicloseTM System2023-08-31
K231553 — OverStitch NXT Endoscopic Suturing System2023-06-29

More clearances from Medeon Biodesign, Inc.

view all

K200902 — ClickClean2020-04-30
K193652 — AbClose - Port Site Closure Device2020-03-26
K192891 — Laparoscope Lens Shield Device (LENS)2019-11-07
K170103 — Laparoscope Lens Shield Device (LENS)2017-02-16
K160172 — Laparoscope Lens Shield Device2016-04-21

Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.