Cleared Traditional

STAMEY NEEDLE

K884553 · Cook Ob/Gyn · General & Plastic Surgery
Nov 1988
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K884553 is an FDA 510(k) clearance for the STAMEY NEEDLE, a Carrier, Ligature (Class I — General Controls, product code GEJ), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on November 14, 1988, 14 days after receiving the submission on October 31, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K884553 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1988
Decision Date November 14, 1988
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEJ — Carrier, Ligature
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800