MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE— 510(k) K052802

Name: FDA 510(k) clearance K052802
Creator: U.S. Food and Drug Administration
Published: 2005-11-01

Substantially Equivalent

Manan Medical Products, Inc.

FDA 510(k) clearance K052802 for MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE, Substantially Equivalent on 2005-11-01. Applicant: Manan Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Manan Medical Products, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2005-10-03
Decision date: 2005-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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K011209 — MANAN SPRITACRE SPINAL NEEDLES2001-06-26
K983620 — MANAN SPINAL NEEDLES1999-01-08
K980536 — EPIDURAL NEEDLE1998-07-31
K981386 — MANAN BLUNT NEEDLE1998-06-29
K980211 — MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES1998-02-06

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.