Cleared Traditional

K790811 - EXETER BONE LAUAGE SYSTEM

K790811 is an FDA 510(k) clearance for EXETER BONE LAUAGE SYSTEM, manufactured by Howmedica Corp.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K790811 · Howmedica Corp. · General Hospital
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Jul 1979
Decision
95d
Days
Class 2
Risk

K790811 is an FDA 510(k) clearance for the EXETER BONE LAUAGE SYSTEM. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 95 days - within the typical 510(k) review window.

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: 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K790811

510(k) Number K790811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1979
Decision Date July 30, 1979
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

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.