Cleared Traditional

K760175 - DRAPE, TRANSURETHRAL RESECTION (TUR) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760175 · V. Mueller O.V. Baxter Healthcare Corp. · General Hospital
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Aug 1976
Decision
55d
Days
Class 2
Risk

K760175 is an FDA 510(k) clearance for the DRAPE, TRANSURETHRAL RESECTION (TUR). Classified as Drape, Pure Latex Sheet, With Self-retaining Finger Cot (product code EYX), Class II - Special Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1976 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date August 30, 1976
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EYX Drape, Pure Latex Sheet, With Self-retaining Finger Cot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.