16 GA X 6 BULLET POINT NEEDLE— 510(k) K894872

Name: FDA 510(k) clearance K894872
Creator: U.S. Food and Drug Administration
Published: 1989-09-22

Substantially Equivalent

R. J. Doyle, Inc.

FDA 510(k) clearance K894872 for 16 GA X 6 BULLET POINT NEEDLE, Substantially Equivalent on 1989-09-22. Applicant: R. J. Doyle, Inc.. Device class: 1.

Clearance details

Applicant: R. J. Doyle, Inc.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1989-08-01
Decision date: 1989-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spirit Lake, ID, US

Download summary PDF View on FDA.gov ↗

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More clearances from R. J. Doyle, Inc.

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K894878 — 16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE1989-11-30
K894879 — 16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE1989-11-30
K894880 — 16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL1989-11-30
K894881 — 20GA X 7-1/2 THREADING BULLET POINT NEEDLE1989-11-30
K894882 — INFILTRATION PUMP SYRINGE1989-11-30

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.