Cleared Traditional

K993242 - CASTLE SURGICAL LIGHT, MODEL 3000

K993242 is an FDA 510(k) clearance for CASTLE SURGICAL LIGHT, 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 42-day FDA review.

K993242 · Getinge/Castle, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
42d
Days
Class 2
Risk

K993242 is an FDA 510(k) clearance for the CASTLE SURGICAL LIGHT, MODEL 3000. 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 November 8, 1999 after a review of 42 days - a notably fast clearance cycle.

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: 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 Getinge/Castle, Inc. devices

FDA 510(k) Submission Details - K993242

510(k) Number K993242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date November 08, 1999
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
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 30
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K993242.
CHROMOPHARE X 65
K024132 · Berchtold Holding GmbH · Mar 2003
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · Skytron, Div. the Kmw Group, Inc. · Nov 2002
STELLAR
K002463 · Skytron, Div. the Kmw Group, Inc. · Nov 2000
MILLENNIUM GOLD
K992090 · Skytron, Div. the Kmw Group, Inc. · Sep 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · Berchtold Holding GmbH · Jul 1999
CHROMOPHARE D500, D530, D650
K991527 · Berchtold Holding GmbH · May 1999