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FDA 510(k)

IALUSET HYDROCOLLOID

K-Number: K020041 · 2002-03-14

ApplicantInstitut Biochimique SA (Ibsa)
Decision Date2002-03-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

IALUSET HYDROCOLLOID is the device name listed in this FDA 510(k) record. The listed applicant is Institut Biochimique SA (Ibsa). It received FDA 510(k) clearance on 2002-03-14 under 510(k) number K020041. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IALUSET HYDROCOLLOID?

IALUSET HYDROCOLLOID is a medical device that received FDA 510(k) clearance on 2002-03-14. The listed applicant is Institut Biochimique SA (Ibsa). The 510(k) number is K020041.

When did IALUSET HYDROCOLLOID receive FDA 510(k) clearance?

IALUSET HYDROCOLLOID received FDA 510(k) clearance on 2002-03-14, under 510(k) number K020041.

Who is the listed applicant for IALUSET HYDROCOLLOID?

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

What is the FDA product code for IALUSET HYDROCOLLOID?

The FDA product code for IALUSET HYDROCOLLOID is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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