PORTO-VAC— 510(k) K771071

Name: FDA 510(k) clearance K771071
Creator: U.S. Food and Drug Administration
Published: 1977-07-14

Substantially Equivalent

Cpac, Inc.

FDA 510(k) clearance K771071 for PORTO-VAC, Substantially Equivalent on 1977-07-14. Applicant: Cpac, Inc.. Device class: 2.

Clearance details

Applicant: Cpac, Inc.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1977-06-14
Decision date: 1977-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cpac, Inc.

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K110867 — STERI-DENT, STERI-SURE2011-07-20
K094026 — STERI-DENT, STERI-SURE2011-07-12
K781486 — STERI-VAC POWER UNITS1978-09-27
K771070 — DRY HEAT STERILIZER1977-07-14

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.