Cleared Traditional

K802851 - GARDNER KUPHOSIS DISTRACTOR (FDA 510(k) Clearance)

K802851 · Downs Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
97d
Days
-
Risk

K802851 is an FDA 510(k) clearance for the GARDNER KUPHOSIS DISTRACTOR.

Submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1981 after a review of 97 days - within the typical 510(k) review window.

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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K802851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1980
Decision Date February 17, 1981
Days to Decision 97 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
17d faster than avg
Panel avg: 114d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -