Cleared Traditional

K974084 - GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

K974084 is an FDA 510(k) clearance for GETINGE/CASTLE OPTIVIEW SERIES SURGICAL..., manufactured by Getinge/Castle, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K974084 · Getinge/Castle, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
125d
Days
Class 2
Risk

K974084 is an FDA 510(k) clearance for the GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Getinge/Castle, Inc. (North Charleston, US). The FDA issued a Cleared decision on March 3, 1998 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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: 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.

View all Getinge/Castle, Inc. devices

FDA 510(k) Submission Details - K974084

510(k) Number K974084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1997
Decision Date March 03, 1998
Days to Decision 125 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSY Light, Surgical, Ceiling Mounted

All 29
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K974084.
CHROMOPHARE D500, D530, D650
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BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433 · Berchtold Holding GmbH · Feb 1998
HANAULUX BLUE 75 AND HANAULUX BLUE 120
K973466 · Heraeus Med GmbH · Oct 1997
CHROMOPHARE
K965130 · Berchtold Holding GmbH · Jul 1997