Cleared Traditional

K964181 - SPONGETRAC

K964181 is an FDA 510(k) clearance for SPONGETRAC, manufactured by Surgitrac Corp.. The device is a Class 1 General Hospital device with product code MRL cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K964181 · Surgitrac Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
131d
Days
Class 1
Risk

K964181 is an FDA 510(k) clearance for the SPONGETRAC. Classified as Scale, Sponge, Surgical, Electrically-powered (product code MRL), Class I - General Controls.

Submitted by Surgitrac Corp. (Washington, US). The FDA issued a Cleared decision on February 26, 1997 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2740 - the FDA general hospital device framework. 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgitrac Corp. devices

FDA 510(k) Submission Details - K964181

510(k) Number K964181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1996
Decision Date February 26, 1997
Days to Decision 131 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 129d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

MRL Device Classification - Class 1, General Controls

Product Code MRL Scale, Sponge, Surgical, Electrically-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.