Cleared Traditional

K935531 - OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K935531 · Puritas Health Care, Inc. · General & Plastic Surgery device
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May 1994
Decision
170d
Days
Class 1
Risk

K935531 is an FDA 510(k) clearance for the OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on May 5, 1994 after a review of 170 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Puritas Health Care, Inc. devices

Submission Details

510(k) Number K935531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date May 05, 1994
Days to Decision 170 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 114d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.