Cleared Traditional

K891023 - SIEMENS CEILING STAND 800F, 800 AND 810

K891023 · Siemens Medical Electronics · General & Plastic Surgery device
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Jul 1989
Decision
147d
Days
-
Risk

K891023 is an FDA 510(k) clearance for the SIEMENS CEILING STAND 800F, 800 AND 810.

Submitted by Siemens Medical Electronics (Danvers, US). The FDA issued a Cleared decision on July 25, 1989 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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FDA 510(k) Submission Details - K891023

510(k) Number K891023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date July 25, 1989
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 40
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