CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM— 510(k) K882105

Name: FDA 510(k) clearance K882105
Creator: U.S. Food and Drug Administration
Published: 1988-07-11

Unknown

Dianon Systems, Inc.

FDA 510(k) clearance K882105 for CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM, Unknown on 1988-07-11. Applicant: Dianon Systems, Inc.. Device class: 1.

Clearance details

Applicant: Dianon Systems, Inc.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-05-19
Decision date: 1988-07-11
Decision: Unknown
Clearance type: Traditional
Location: Stratford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAA

view all

K223625 — CapnoSpot Pneumothorax Decompression Indicator2023-03-28
K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT2011-06-15
K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE2001-11-16
K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES2000-03-01
K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX1998-12-11

More clearances from Dianon Systems, Inc.

view all

K872597 — FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE1987-07-28

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.