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FDA 510(k)

INTRASITE* GEL (3) YEAR SHELF LIFE

K-Number: K891870 · 1989-08-09

ApplicantSmith & Nephew United, Inc.
Decision Date1989-08-09
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

INTRASITE* GEL (3) YEAR SHELF LIFE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1989-08-09 under 510(k) number K891870. 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 INTRASITE* GEL (3) YEAR SHELF LIFE?

INTRASITE* GEL (3) YEAR SHELF LIFE is a medical device that received FDA 510(k) clearance on 1989-08-09. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K891870.

When did INTRASITE* GEL (3) YEAR SHELF LIFE receive FDA 510(k) clearance?

INTRASITE* GEL (3) YEAR SHELF LIFE received FDA 510(k) clearance on 1989-08-09, under 510(k) number K891870.

Who is the listed applicant for INTRASITE* GEL (3) YEAR SHELF LIFE?

The FDA 510(k) record lists Smith & Nephew United, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRASITE* GEL (3) YEAR SHELF LIFE?

The FDA product code for INTRASITE* GEL (3) YEAR SHELF LIFE is FRO. This falls under the Anesthesiology category.

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Other records listing Smith & Nephew United, Inc. as applicant

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Related Devices (Code: FRO)

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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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