Cleared Traditional

K840378 - ADJUST-A-TEMP EXTRA FINE TIP (FDA 510(k) Clearance)

K840378 · Suncoast Medical Manufacturers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
-
Days
-
Risk

K840378 is an FDA 510(k) clearance for the ADJUST-A-TEMP EXTRA FINE TIP.

Submitted by Suncoast Medical Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984.

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 Suncoast Medical Manufacturers, Inc. devices

Submission Details

510(k) Number K840378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 27, 1984
Decision Date January 27, 1984
Days to Decision -
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -