STERILIZER WRAP - 6

FDA 510(k)

Class II (US FDA 510(k))

510(k) K760661

Identifiers

510(k) Number: K760661 FDA 510(k)
FDA Product Code: FRG FDA 510(k)
Models / Variants: cat#221831 FDA 510(k)
2 FDA 510(k)
3 FDA 510(k)
4 FDA 510(k)
5 FDA 510(k)
6 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.6850 FDA 510(k)
Regulation Number: 880.6850 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Sterilizer Wrap is a medical device designed for use in sterilization processes. It is classified as Wrap, Sterilization under product code FRG and serves to maintain sterility of medical instruments during storage and handling.

The device is supplied in multiple sizes (Cat#221831,2,3,4,5,6) and is intended for single-use applications. It received FDA 510(k) clearance K760661 on December 2, 1976, with a decision of Substantially Equivalent.

Frequently asked questions

What is the purpose of the STERILIZER WRAP?

The STERILIZER WRAP is designed to maintain sterility of medical instruments during storage and handling as part of sterilization processes.

How many sizes are available for the STERILIZER WRAP?

The STERILIZER WRAP is supplied in multiple sizes with catalog numbers 221831, 2, 3, 4, 5, and 6 to accommodate various instrument sizes.

Is the STERILIZER WRAP reusable or single-use?

The STERILIZER WRAP is intended for single-use applications and should not be reused to ensure proper sterilization maintenance.

What regulatory clearance does the STERILIZER WRAP have?

The STERILIZER WRAP received FDA 510(k) clearance K760661 on December 2, 1976, with a decision of Substantially Equivalent.

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: STERILIZER WRAP (CAT#221831,2,3,4,5,6) - Innolitics, STERILIZER WRAP (CAT#221831,2,3,4,5,6) (K760661) - FDA 510 (k), PDF K760661 - Sterilizer Wrap (Cat#221831,2,3,4,5,6), Sterilizer Wrap (cat#221831,2,3,4,5,6) 510(k) K760661 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K760661	Class II	Active

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Manufacturer

Manufacturer: C. R. Bard, Inc.
FDA Applicant: C.R. Bard, Inc.

Sources (1)

FDA 510(k) K760661 24 fields · synced Sep 19, 2026