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FDA 510(k)

CASTLE SURGICAL LIGHT, MODEL 3000

K-Number: K993242 · 1999-11-08

ApplicantGetinge/Castle, Inc.
Decision Date1999-11-08
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CASTLE SURGICAL LIGHT, MODEL 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Getinge/Castle, Inc.. It received FDA 510(k) clearance on 1999-11-08 under 510(k) number K993242. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASTLE SURGICAL LIGHT, MODEL 3000?

CASTLE SURGICAL LIGHT, MODEL 3000 is a medical device that received FDA 510(k) clearance on 1999-11-08. The listed applicant is Getinge/Castle, Inc.. The 510(k) number is K993242.

When did CASTLE SURGICAL LIGHT, MODEL 3000 receive FDA 510(k) clearance?

CASTLE SURGICAL LIGHT, MODEL 3000 received FDA 510(k) clearance on 1999-11-08, under 510(k) number K993242.

Who is the listed applicant for CASTLE SURGICAL LIGHT, MODEL 3000?

The FDA 510(k) record lists Getinge/Castle, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASTLE SURGICAL LIGHT, MODEL 3000?

The FDA product code for CASTLE SURGICAL LIGHT, MODEL 3000 is FSY.

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Other records listing Getinge/Castle, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K020205CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KITK020590MODEL 733HC GRAVITY/VACUUM STEAM STERILIZERK012573CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HCK003441CASTLE MODEL 233HC STEAM STERILIZERK994314CASTLE SERIES 100HC STEAM STERILIZERSK974084GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

View all 9 devices →

Related Devices (Code: FSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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