Cleared Traditional

K933772 - PUNCH SURGICAL (FDA 510(k) Clearance)

Class I Orthopedic device.

K933772 · Mahe-Medizintechnik · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
187d
Days
Class 1
Risk

K933772 is an FDA 510(k) clearance for the PUNCH SURGICAL. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Mahe-Medizintechnik (Nashville, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 187 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 Mahe-Medizintechnik devices

Submission Details

510(k) Number K933772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date February 01, 1994
Days to Decision 187 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
65d slower than avg
Panel avg: 122d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXH Orthopedic Manual Surgical Instrument
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.