PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP— 510(k) K991002

Name: FDA 510(k) clearance K991002
Creator: U.S. Food and Drug Administration
Published: 1999-06-11

Substantially Equivalent

V. Mueller Neuro/Spine

FDA 510(k) clearance K991002 for PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP, Substantially Equivalent on 1999-06-11. Applicant: V. Mueller Neuro/Spine. Device class: 2.

Clearance details

Applicant: V. Mueller Neuro/Spine
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 1999-03-25
Decision date: 1999-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, 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 V. Mueller Neuro/Spine

view all

K002276 — PSI SKULL CLAMP2000-08-29
K993019 — PACIFIC SURGICAL PATTIES2000-03-30
K991959 — PSI TITANIUM ANEURYSM CLIP2000-01-06
K972750 — TAKA ANEURYSM CLIP1998-07-09
K964402 — VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM1997-01-23

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.