Cleared Traditional

K973747 - CONTROLLED TEMPERATURE CABINET SYSTEM

K973747 · Smith · General & Plastic Surgery device
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May 1998
Decision
218d
Days
-
Risk

K973747 is an FDA 510(k) clearance for the CONTROLLED TEMPERATURE CABINET SYSTEM.

Submitted by Smith (Crofton, US). The FDA issued a Cleared decision on May 7, 1998 after a review of 218 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K973747

510(k) Number K973747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1997
Decision Date May 07, 1998
Days to Decision 218 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 115d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 39
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