GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN— 510(k) K864193

Name: FDA 510(k) clearance K864193
Creator: U.S. Food and Drug Administration
Published: 1986-11-17

Substantially Equivalent

Gaw, Inc.

FDA 510(k) clearance K864193 for GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN, Substantially Equivalent on 1986-11-17. Applicant: Gaw, Inc.. Device class: 1.

Clearance details

Applicant: Gaw, Inc.
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-10-27
Decision date: 1986-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDM

view all

K071732 — MARROWMINER2007-09-24
K971114 — BIOACCESS MARROW HARVEST SYSTEM1997-06-03
K953082 — ILIAC CREST BONE MARROW ASPIRATION NEEDLE1995-09-22
K953064 — BIOACCESS MARROW HARVEST SYSTEM1995-08-07
K936207 — ENDO-NEEDLE INSTRUMENT1994-06-16

Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.