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FDA 510(k)

DISARP ORIGINAL

K-Number: K802248 · 1980-09-26

ApplicantUnoplast A/S
Decision Date1980-09-26
Product CodeGAO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISARP ORIGINAL is the device name listed in this FDA 510(k) record. The listed applicant is Unoplast A/S. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802248. The device is classified under product code GAO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISARP ORIGINAL?

DISARP ORIGINAL is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Unoplast A/S. The 510(k) number is K802248.

When did DISARP ORIGINAL receive FDA 510(k) clearance?

DISARP ORIGINAL received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802248.

Who is the listed applicant for DISARP ORIGINAL?

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

What is the FDA product code for DISARP ORIGINAL?

The FDA product code for DISARP ORIGINAL is GAO.

Related Clinical Trials

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Other records listing Unoplast A/S 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.

K896734FEEDING TUBEK896729NELATON-, FEMALE - OR TIEMANN CATHETERK896732UNOMETER 500K896730SUCTION CATHETER STRAIGHT/COUDEK896731OXYGEN CATHETERSK896733VACCON

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Related Devices (Code: GAO)

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.

K932513LABELING FOR MYO/WIRE II STERNOTOMY SUTURESAlto Development Corp.K872532AUTO SUTURE STAINLESS STEEL SUTURES*United States Surgical, A Division of Tyco HealthcK863034SHARPOINT STAINLESS STEEL SUTUREChathamborough Research Group, Inc.

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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