Cleared Traditional

K845023 - STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000

K845023 is an FDA 510(k) clearance for STORZ PLASTIC SURGERY & EXAMINATION LOU..., manufactured by Storz Instrument Co.. The device is a Class 1 General Hospital device with product code LGX cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K845023 · Storz Instrument Co. · General Hospital
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Jan 1985
Decision
32d
Days
Class 1
Risk

K845023 is an FDA 510(k) clearance for the STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000. Classified as Table, Examination, Medical, Powered (product code LGX), Class I - General Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on January 28, 1985 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4960 - 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 Storz Instrument Co. devices

FDA 510(k) Submission Details - K845023

510(k) Number K845023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date January 28, 1985
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

LGX Device Classification - Class 1, General Controls

Product Code LGX Table, Examination, Medical, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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 - LGX Table, Examination, Medical, Powered

All 7
Devices cleared under the same product code (LGX) and FDA review panel - the closest regulatory comparables to K845023.
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