Cleared Traditional

K873272 - ENDOSCOPY TABLE 1532 ENDOSTAR

K873272 is an FDA 510(k) clearance for ENDOSCOPY TABLE 1532 ENDOSTAR, manufactured by Stierlen-Maquet AG. The device is a Class 1 General & Plastic Surgery device with product code BWN cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K873272 · Stierlen-Maquet AG · General & Plastic Surgery device
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Sep 1987
Decision
22d
Days
Class 1
Risk

K873272 is an FDA 510(k) clearance for the ENDOSCOPY TABLE 1532 ENDOSTAR. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Stierlen-Maquet AG (West Germany, GR). The FDA issued a Cleared decision on September 8, 1987 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery 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 Stierlen-Maquet AG devices

FDA 510(k) Submission Details - K873272

510(k) Number K873272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date September 08, 1987
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

BWN Device Classification - Class 1, General Controls

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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 - BWN Table And Attachments, Operating-room

Devices cleared under the same product code (BWN) and FDA review panel - the closest regulatory comparables to K873272.
BAUMER SURGICAL TABLE
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