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FDA 510(k)

STERILIZER, SERIES 3000, MODIFICATION TO

K-Number: K770682 · 1977-05-20

ApplicantCastle Co.
Decision Date1977-05-20
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILIZER, SERIES 3000, MODIFICATION TO is the device name listed in this FDA 510(k) record. The listed applicant is Castle Co.. It received FDA 510(k) clearance on 1977-05-20 under 510(k) number K770682. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILIZER, SERIES 3000, MODIFICATION TO?

STERILIZER, SERIES 3000, MODIFICATION TO is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Castle Co.. The 510(k) number is K770682.

When did STERILIZER, SERIES 3000, MODIFICATION TO receive FDA 510(k) clearance?

STERILIZER, SERIES 3000, MODIFICATION TO received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770682.

Who is the listed applicant for STERILIZER, SERIES 3000, MODIFICATION TO?

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

What is the FDA product code for STERILIZER, SERIES 3000, MODIFICATION TO?

The FDA product code for STERILIZER, SERIES 3000, MODIFICATION TO is FLE.

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Other records listing Castle Co. 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.

K870975MODIFIED CASTLE POWERCLAVEK860263CASTLE 7538 FLOOR LOADING WASHERK844089CASTLE 7515 UTENSIL/GLASSWARE WASHERK834048BOVIE CONDUCTIVE ADHES-DISPER-ELECTROK833074CASTLE TEC-TEST S.M.A.R.T. PACKK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AER

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Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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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