VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS— 510(k) K895920

Name: FDA 510(k) clearance K895920
Creator: U.S. Food and Drug Administration
Published: 1991-06-06

Substantially Equivalent

Vitaphore Corp.

FDA 510(k) clearance K895920 for VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS, Substantially Equivalent on 1991-06-06. Applicant: Vitaphore Corp.. Device class: 1.

Clearance details

Applicant: Vitaphore Corp.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1989-10-11
Decision date: 1991-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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K902558 — COLLAGEN SHIELD FOR ACUTE CARE1990-08-17
K891993 — COLLAGEN NEUROSPONGE1990-03-23
K896455 — VITACHOICE WOUND DRESSING1990-02-15

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.