Cleared Traditional

K973803 - FLEXVIEW CO2 BLOWER WITH MIST (FDA 510(k) Clearance)

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

K973803 · Ethicon Endo-Surgery, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
71d
Days
Class 2
Risk

K973803 is an FDA 510(k) clearance for the FLEXVIEW CO2 BLOWER WITH MIST. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 16, 1997 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - 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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K973803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date December 16, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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.

Regulatory Peers - FQH Lavage, Jet

All 52
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