Cleared Traditional

K821358 - MODIFIED RONGEURS FOR SPINAL & ORTH. S.

K821358 is an FDA 510(k) clearance for MODIFIED RONGEURS FOR SPINAL & ORTH. S., manufactured by Downs Surgical , Ltd.. The device is a Class 1 Dental device with product code EMH cleared through the Traditional 510(k) pathway after a 22-day FDA review.

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

FDA 510(k) Submission Details - K821358

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

EMH Device Classification - Class 1, General Controls

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.

Regulatory Peers - EMH Forceps, Rongeur, Surgical

Devices cleared under the same product code (EMH) and FDA review panel - the closest regulatory comparables to K821358.
MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT
K854887 · Walter Lorenz Surgical, Inc. · Feb 1986
586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC
K851710 · Artiberia · Jun 1985
JAKOBI SURG. INSTRUMENTS #8 15
K834190 · Imm Enterprises , Ltd. · Mar 1984
FORCEPS, STYLE #849
K771522 · Premier Dental Products Co. · Aug 1977