Cleared Traditional

DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET (K924837) - FDA 510(k) Clearance

K924837 · Associated Ent., Inc. · General & Plastic Surgery device
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Oct 1993
Decision
382d
Days
-
Risk

K924837 is an FDA 510(k) clearance for the DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET.

Submitted by Associated Ent., Inc. (Jonesborough, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Associated Ent., Inc. devices

Submission Details

510(k) Number K924837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1992
Decision Date October 12, 1993
Days to Decision 382 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
267d slower than avg
Panel avg: 115d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -