Cleared Traditional

THE ELEVENTH FINGER (K923835) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K923835 · Guardian Angel Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
343d
Days
Class 1
Risk

K923835 is an FDA 510(k) clearance for the THE ELEVENTH FINGER. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Guardian Angel Products, Inc. (Washington, US). The FDA issued a Cleared decision on July 9, 1993 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Guardian Angel Products, Inc. devices

Submission Details

510(k) Number K923835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1992
Decision Date July 09, 1993
Days to Decision 343 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 115d · This submission: 343d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDF Guide, Needle, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.