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3M Brand Laser Protection Surgical Drapes 88XX

FDA 510(k)

Class II (US FDA 510(k))

510(k) K874086

by 3m Company

Identifiers

510(k) Number
K874086 FDA 510(k)
FDA Product Code
KKX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a surgical drape designed for laser protection, classified as a Drape, Surgical under product code KKX. It is intended for use in general and plastic surgery settings to provide a barrier against laser energy during procedures.

The device is supplied as a sterile, single-use surgical drape. It received FDA 510(k) clearance (K874086) on December 17, 1987, and is classified as a Class II device with special controls. No information is provided regarding MRI safety, sizes, storage conditions, or reusability beyond its single-use nature as implied by its classification and intended use.

Frequently asked questions

What is the 3M Brand Laser Protection Surgical Drape 88XX used for?

It is intended for use in general and plastic surgery settings to provide a barrier against laser energy during procedures, protecting both patient and surgical team from inadvertent laser exposure.

Is the 3M Brand Laser Protection Surgical Drape 88XX sterile and single-use?

Yes, the device is supplied as a sterile, single-use surgical drape, meaning it is designed for one procedure only and must be discarded after use to maintain sterility and prevent cross-contamination.

What regulatory pathway was used for the 3M Brand Laser Protection Surgical Drape 88XX?

The device received FDA 510(k) clearance under submission K874086 on December 17, 1987, and is classified as a Class II device with special controls, indicating it was found substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3M BRAND LASER PROTECTION SURGICAL DRAP... (K874086) - FDA 510(k), 3m Brand Laser Protection Surgical Drapes, 88xx… - FDA.report, 3M Surgical Drapes for Medical | 3M United States

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA 510(k) K874086 24 fields · synced Sep 24, 2026