MUCUS SPECIMEN TRAP— 510(k) K962168

Name: FDA 510(k) clearance K962168
Creator: U.S. Food and Drug Administration
Published: 1996-07-22

Substantially Equivalent

Sage Products, Inc.

FDA 510(k) clearance K962168 for MUCUS SPECIMEN TRAP, Substantially Equivalent on 1996-07-22. Applicant: Sage Products, Inc.. Device class: 2.

Clearance details

Applicant: Sage Products, Inc.
Product code: Code KDQ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1996-06-05
Decision date: 1996-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crystal Lake, IL, US

Download summary PDF View on FDA.gov ↗

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K972705 — RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC1998-04-30
K980490 — SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS1998-02-24
K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER1997-10-29
K972279 — SHARPS SHUTTLE1997-08-29
K970135 — NITRILE GLOVES1997-08-25

Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.