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FDA 510(k)

Chemical Indicator for enspire CLCSPS (LCC015)

K-Number: K243475 · 2024-12-04

ApplicantSTERIS Corporation
Decision Date2024-12-04
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chemical Indicator for enspire CLCSPS (LCC015) is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K243475. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chemical Indicator for enspire CLCSPS (LCC015)?

Chemical Indicator for enspire CLCSPS (LCC015) is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is STERIS Corporation. The 510(k) number is K243475.

When did Chemical Indicator for enspire CLCSPS (LCC015) receive FDA 510(k) clearance?

Chemical Indicator for enspire CLCSPS (LCC015) received FDA 510(k) clearance on 2024-12-04, under 510(k) number K243475.

Who is the listed applicant for Chemical Indicator for enspire CLCSPS (LCC015)?

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

What is the FDA product code for Chemical Indicator for enspire CLCSPS (LCC015)?

The FDA product code for Chemical Indicator for enspire CLCSPS (LCC015) is JOJ.

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Related Devices (Code: JOJ)

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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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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