Cleared Traditional

K872947 - POREX QUALITY PLASTIC SURGERY INSTRUMENTS

K872947 is an FDA 510(k) clearance for POREX QUALITY PLASTIC SURGERY INSTRUMENTS, manufactured by Porex Medical. The device is a Class 1 General & Plastic Surgery device with product code KDG cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K872947 · Porex Medical · General & Plastic Surgery device
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Aug 1987
Decision
24d
Days
Class 1
Risk

K872947 is an FDA 510(k) clearance for the POREX QUALITY PLASTIC SURGERY INSTRUMENTS. Classified as Chisel (osteotome) (product code KDG), Class I - General Controls.

Submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on August 21, 1987 after a review of 24 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 Porex Medical devices

FDA 510(k) Submission Details - K872947

510(k) Number K872947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1987
Decision Date August 21, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

KDG Device Classification - Class 1, General Controls

Product Code KDG Chisel (osteotome)
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 - KDG Chisel (osteotome)

Devices cleared under the same product code (KDG) and FDA review panel - the closest regulatory comparables to K872947.
SIL-MED WASTE FLUID DUMP BAG
K891471 · Sil-Med Corp. · Aug 1989
OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5
K872092 · Military Engineering, Inc. · Jun 1987
ANDERSON-NEIVERT OSTEOTOME
K772373 · Edward Weck, Inc. · Mar 1978
SILVER OSTEOTOME
K772374 · Edward Weck, Inc. · Mar 1978
NEIVERT OSTEOTOME
K772376 · Edward Weck, Inc. · Mar 1978
CEMENT EXTRACTION INSTRUMENT SET
K780135 · Orthopedic Equipment Co., Inc. · Jan 1978