Hem-o-lok® Ligating Clips— 510(k) K232970

Name: FDA 510(k) clearance K232970
Creator: U.S. Food and Drug Administration
Published: 2024-01-12

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K232970 for Hem-o-lok® Ligating Clips, Substantially Equivalent on 2024-01-12. Applicant: Teleflex Medical. Device class: 2.

Clearance details

Applicant: Teleflex Medical
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2023-09-21
Decision date: 2024-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZP

view all

K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips2026-07-20
K253781 — InnoClip Clip Applier2025-12-22
K253903 — InnoClip Disposable Clip Applier2025-12-22
K250643 — Disposable Polymer Ligation Clips2025-11-20
K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips2025-07-03

More clearances from Teleflex Medical

view all

K242495 — LMA Fastrach ETT SU2025-04-29
K243553 — QuikClot Control+ Hemostatic Device2025-03-18
K241784 — Arrow® Nitinol Wire2024-09-18
K233713 — Pilling Tracheostomy Tubes2024-03-22
K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more2023-08-30

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.