P/2000— 510(k) K944411

Name: FDA 510(k) clearance K944411
Creator: U.S. Food and Drug Administration
Published: 1994-12-27

Substantially Equivalent

Plexus Medical

FDA 510(k) clearance K944411 for P/2000, Substantially Equivalent on 1994-12-27. Applicant: Plexus Medical. Device class: 2.

Clearance details

Applicant: Plexus Medical
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1994-09-08
Decision date: 1994-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covina, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Plexus Medical

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K952610 — PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)1995-09-13
K943353 — PLEXUS/10001994-12-12

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.