Cleared Traditional

K944238 - ENDOCYTE TM

K944238 is an FDA 510(k) clearance for ENDOCYTE TM, manufactured by D.L. Nelson and Assoc., Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HCY cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K944238 · D.L. Nelson and Assoc., Inc. · Obstetrics & Gynecology device
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Sep 1995
Decision
380d
Days
Class 1
Risk

K944238 is an FDA 510(k) clearance for the ENDOCYTE TM. Classified as Curette, Uterine (product code HCY), Class I - General Controls.

Submitted by D.L. Nelson and Assoc., Inc. (Atlanta, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all D.L. Nelson and Assoc., Inc. devices

FDA 510(k) Submission Details - K944238

510(k) Number K944238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 160d · This submission: 380d
Pathway characteristics
Predicate-based equivalence.

HCY Device Classification - Class 1, General Controls

Product Code HCY Curette, Uterine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.