MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY— 510(k) K854291

Name: FDA 510(k) clearance K854291
Creator: U.S. Food and Drug Administration
Published: 1985-11-26

Substantially Equivalent

Medsurg Industries, Inc.

FDA 510(k) clearance K854291 for MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY, Substantially Equivalent on 1985-11-26. Applicant: Medsurg Industries, Inc.. Device class: 2.

Clearance details

Applicant: Medsurg Industries, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1985-10-25
Decision date: 1985-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, US

Download summary PDF View on FDA.gov ↗

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K940175 — MEDSURG STERILE O.R. TOWELS1994-05-26
K934731 — MEDSURG STERILE IMAGING PRODUCTS1994-03-28
K925558 — INFILTUBE1994-03-04
K934971 — STERILE LAPAROTOMY SPONGES1994-02-07

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.