Cleared Traditional

ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) (K932714) - FDA 510(k) Clearance

K932714 · Surface Mount Technology, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
180d
Days
-
Risk

K932714 is an FDA 510(k) clearance for the ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM).

Submitted by Surface Mount Technology, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 1, 1993 after a review of 180 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.

View all Surface Mount Technology, Inc. devices

Submission Details

510(k) Number K932714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1993
Decision Date December 01, 1993
Days to Decision 180 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 115d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -