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FDA 510(k)

SANICLAVE 200

K-Number: K112811 · 2012-01-11

ApplicantAlternative Pioneering Research and Development
Decision Date2012-01-11
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SANICLAVE 200 is the device name listed in this FDA 510(k) record. The listed applicant is Alternative Pioneering Research and Development. It received FDA 510(k) clearance on 2012-01-11 under 510(k) number K112811. 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 SANICLAVE 200?

SANICLAVE 200 is a medical device that received FDA 510(k) clearance on 2012-01-11. The listed applicant is Alternative Pioneering Research and Development. The 510(k) number is K112811.

When did SANICLAVE 200 receive FDA 510(k) clearance?

SANICLAVE 200 received FDA 510(k) clearance on 2012-01-11, under 510(k) number K112811.

Who is the listed applicant for SANICLAVE 200?

The FDA 510(k) record lists Alternative Pioneering Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANICLAVE 200?

The FDA product code for SANICLAVE 200 is FLE.

Related Clinical Trials

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.

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Other records listing Alternative Pioneering Research and Development 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.

K122978SANICLAVE 102, MODEL RS-SC-102

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

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

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