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FDA 510(k)

STATIM CASSETTE AUTOCLAVE

K-Number: K910241 · 1991-05-03

ApplicantScican
Decision Date1991-05-03
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STATIM CASSETTE AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Scican. It received FDA 510(k) clearance on 1991-05-03 under 510(k) number K910241. 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 STATIM CASSETTE AUTOCLAVE?

STATIM CASSETTE AUTOCLAVE is a medical device that received FDA 510(k) clearance on 1991-05-03. The listed applicant is Scican. The 510(k) number is K910241.

When did STATIM CASSETTE AUTOCLAVE receive FDA 510(k) clearance?

STATIM CASSETTE AUTOCLAVE received FDA 510(k) clearance on 1991-05-03, under 510(k) number K910241.

Who is the listed applicant for STATIM CASSETTE AUTOCLAVE?

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

What is the FDA product code for STATIM CASSETTE AUTOCLAVE?

The FDA product code for STATIM CASSETTE AUTOCLAVE is FLE.

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Other records listing Scican 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.

K062418K-SPRAY, MODEL 085-2715K021064QUANTIM 16 AUTOCLAVEK983679STATIM 5000 CASSETTE AUTOCLAVEK964691TCB TEMPORARY CROWN AND BRIDGE MATERIALK962179STAT IM 5000 CASSETTE AUTOCLAVEK944036STERIMASTER AUTOCLAVE

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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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