Cleared Traditional

K841298 - HOLE CHAMFERING DEVICE

K841298 is an FDA 510(k) clearance for HOLE CHAMFERING DEVICE, manufactured by Techmedica, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K841298 · Techmedica, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
26d
Days
Class 1
Risk

K841298 is an FDA 510(k) clearance for the HOLE CHAMFERING DEVICE. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by Techmedica, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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: 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 Techmedica, Inc. devices

FDA 510(k) Submission Details - K841298

510(k) Number K841298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1984
Decision Date April 25, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

GFF Device Classification - Class 1, General Controls

Product Code GFF Bur, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - GFF Bur, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GFF) and FDA review panel - the closest regulatory comparables to K841298.
DANEK IRRIGATING BURR (DIB) SET
K890090 · Danek Medical, Inc. · Jan 1989
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · Micro-Aire Surgical Instruments, Inc. · Aug 1986
MICRO-AIRE GENERIC BURS & DRILLS
K850497 · Micro-Aire Surgical Instruments, Inc. · Mar 1985
MICRO-AIRE REPLACEMENT DRILL BURS
K820281 · Micro-Aire Surgical Instruments, Inc. · Feb 1982