Shur-Strip Applicator

FDA 510(k) K821763 · Shur Medical Corp.

Substantially Equivalent

510(k) numberK821763

Submission

Device name
Shur-Strip Applicator
Applicant
Shur Medical Corp.
Mchenry, IL, US
Received
June 15, 1982
Decision date
June 23, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FPX – Strip, Adhesive, Closure, Skin
Device class
Class I (low risk)
Regulation
21 CFR 880.5240
Specialty
General Hospital

Other 510(k)s with product code FPX

510(k)DeviceApplicantDecision
K970441K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional Medi-Flex Hospital Products, Inc.05/09/1997SE
K952947Delpore Skin ClosureFPX · Traditional Bitco Intl.07/24/1995SE
K952702Derma SealFPX · Traditional Ttl Medical06/28/1995SE
K946321Biostrip Sterile Wound Closure StripFPX · Traditional Cornelia Damsky, Inc.01/12/1995SE
K931005Dukal Skin Closure StripFPX · Traditional Dukal Corp.07/14/1993SE
K921775Spyroflex Wound ClosuresFPX · Traditional Polymint Industrial Co. , Ltd.05/19/1992SE
K894802Awc Butterfly Wound ClosuresFPX · Traditional American White Cross, Inc.01/31/1990SE
K894205Tecnol Silk StripFPX · Traditional Tecnol New Jersey Wound Care, Inc.07/25/1989SE
K874813Omed Wound Closure StripsFPX · Traditional Oxboro Medical Intl., Inc.01/29/1988SE
K840945Skin ClosureFPX · Traditional Gainor Medical10/31/1984SE

More from Gainor Medical

510(k)DeviceDecision
K803012Shur-Patch Tape PatchGXY · Traditional 12/30/1980SE
K790140Skin Closure Tapes SterileFPX · Traditional 02/27/1979SE

Questions and answers

When was Shur-Strip Applicator cleared by the FDA?

Shur-Strip Applicator (K821763) received a 510(k) decision of Substantially Equivalent on June 23, 1982, 8 days after the submission was received.

What is the product code of K821763?

The FDA product code is FPX – Strip, Adhesive, Closure, Skin, a Class I (low risk) device regulated under 21 CFR 880.5240.