Cleared Traditional

K930784 - THE DE SOUTTER M193 REAMER

K930784 is an FDA 510(k) clearance for THE DE SOUTTER M193 REAMER, manufactured by De Soutter Medical, Ltd.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K930784 · De Soutter Medical, Ltd. · Orthopedic device
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Oct 1993
Decision
253d
Days
Class 1
Risk

K930784 is an FDA 510(k) clearance for the THE DE SOUTTER M193 REAMER. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by De Soutter Medical, Ltd. (Kings Langley Herts, GB). The FDA issued a Cleared decision on October 27, 1993 after a review of 253 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 De Soutter Medical, Ltd. devices

FDA 510(k) Submission Details - K930784

510(k) Number K930784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date October 27, 1993
Days to Decision 253 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
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 - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 39
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K930784.
PNEUMATIC WIRE TENSIONER
K942760 · Smith & Nephew Richards, Inc. · Sep 1994
ARTHREX CIRCULAR HARVESTING SAW
K941681 · Arthrex, Inc. · Aug 1994
PNEUMATIC WIRE TENSIONER
K934431 · Smith & Nephew Richards, Inc. · Jan 1994
THE DE SOUTTER M182 DRILL
K930785 · De Soutter Medical, Ltd. · Oct 1993
MEDNEXT 1000 BONE DISSECTING SYSTEM
K926547 · Mednext, Inc. · Jul 1993
HHI PNEUMATIC ROTARY DRILL
K922661 · H&H Instruments · Sep 1992