Cleared Traditional

K961930 - CHONDROPROTEC (FDA 510(k) Clearance)

K961930 · The Hymed Group Corp. · General & Plastic Surgery device
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Oct 1996
Decision
151d
Days
-
Risk

K961930 is an FDA 510(k) clearance for the CHONDROPROTEC. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by The Hymed Group Corp. (Bethlehem, US). The FDA issued a Cleared decision on October 15, 1996 after a review of 151 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 The Hymed Group Corp. devices

Submission Details

510(k) Number K961930 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 17, 1996
Decision Date October 15, 1996
Days to Decision 151 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
37d slower than avg
Panel avg: 114d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -