Cleared Traditional

CUSTOM STERILE PROCEDURE KITS (K842356) - FDA 510(k) Clearance

K842356 · Sterile Design, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
279d
Days
-
Risk

K842356 is an FDA 510(k) clearance for the CUSTOM STERILE PROCEDURE KITS.

Submitted by Sterile Design, Inc. (Oldsmar, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 279 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 Sterile Design, Inc. devices

Submission Details

510(k) Number K842356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date March 21, 1985
Days to Decision 279 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
164d slower than avg
Panel avg: 115d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -