Cleared Traditional

K944238 - ENDOCYTE TM
(FDA 510(k) Clearance)

K944238 · D.L. Nelson and Assoc., Inc. · Obstetrics & Gynecology

Sep 1995

Decision

380d

Days

Class 1

Risk

K944238 is an FDA 510(k) clearance for the ENDOCYTE TM. This device is classified as a Curette, Uterine (Class I — General Controls, product code HCY).

Submitted by D.L. Nelson and Assoc., Inc. (Atlanta, US). The FDA issued a Cleared decision on September 15, 1995, 380 days after receiving the submission on August 31, 1994.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K944238 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1994
Decision Date	September 15, 1995
Days to Decision	380 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement