Cleared Traditional

K942906 - AGEE-WRISTJACK PRE-DRILL KIT

K942906 is an FDA 510(k) clearance for AGEE-WRISTJACK PRE-DRILL KIT, manufactured by Hand Biomechanics Lab, Inc.. The device is a Class 1 Orthopedic device with product code HTW cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K942906 · Hand Biomechanics Lab, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
184d
Days
Class 1
Risk

K942906 is an FDA 510(k) clearance for the AGEE-WRISTJACK PRE-DRILL KIT. Classified as Bit, Drill (product code HTW), Class I - General Controls.

Submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 22, 1994 after a review of 184 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Hand Biomechanics Lab, Inc. devices

FDA 510(k) Submission Details - K942906

510(k) Number K942906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1994
Decision Date December 22, 1994
Days to Decision 184 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 122d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

HTW Device Classification - Class 1, General Controls

Product Code HTW Bit, Drill
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.