NATIONAL-STANDARD NEEDLE HOLDER— 510(k) K881956

Name: FDA 510(k) clearance K881956
Creator: U.S. Food and Drug Administration
Published: 1988-05-20

Substantially Equivalent

N-S Medical Products

FDA 510(k) clearance K881956 for NATIONAL-STANDARD NEEDLE HOLDER, Substantially Equivalent on 1988-05-20. Applicant: N-S Medical Products. Device class: 2.

Clearance details

Applicant: N-S Medical Products
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1988-05-10
Decision date: 1988-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from N-S Medical Products

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K880287 — TRU-TRAC COILED GUIDEWIRE1988-09-12
K880288 — TRU-TRAC TORQUE GUIDEWIRE1988-09-12
K881957 — HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT1988-05-20
K870523 — HAWKINS BREAST LOCALIZATION NEEDLE1987-03-09

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.