CSPI SPECIMEN TRAP (NON-STERILE)— 510(k) K870874

Name: FDA 510(k) clearance K870874
Creator: U.S. Food and Drug Administration
Published: 1988-04-19

Substantially Equivalent

Custom Surgical Products, Inc.

FDA 510(k) clearance K870874 for CSPI SPECIMEN TRAP (NON-STERILE), Substantially Equivalent on 1988-04-19. Applicant: Custom Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Custom Surgical Products, Inc.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1987-03-03
Decision date: 1988-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bossier City, LA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Custom Surgical Products, Inc.

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K841249 — SUCTION CANNULAS1984-06-04
K841383 — CSPI ROTARY SURGICAL ASPIRATOR1984-03-26
K841242 — CSPI PREMIUM SURGICAL ASPIRATOR1984-03-23

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.