Cleared Traditional

K821358 - MODIFIED RONGEURS FOR SPINAL & ORTH. S. (FDA 510(k) Clearance)

Class I Dental device.

K821358 · Downs Surgical , Ltd. · Dental device
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May 1982
Decision
22d
Days
Class 1
Risk

K821358 is an FDA 510(k) clearance for the MODIFIED RONGEURS FOR SPINAL & ORTH. S.. Classified as Forceps, Rongeur, Surgical (product code EMH), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Downs Surgical , Ltd. devices

Submission Details

510(k) Number K821358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1982
Decision Date May 28, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMH Forceps, Rongeur, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.