Cleared Traditional

K935531 - OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP

K935531 is an FDA 510(k) clearance for OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP, manufactured by Puritas Health Care, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 170-day FDA review.

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

FDA 510(k) Submission Details - K935531

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

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.

Regulatory Peers - GBX Catheter, Irrigation

All 41
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K935531.
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