FPX · Strip, Adhesive, Closure, Skin
General Hospital · 21 CFR 880.5240 · Class 1
Overview
| Product Code | FPX |
|---|---|
| Device Name | Strip, Adhesive, Closure, Skin |
| Regulation | 21 CFR 880.5240 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970441 | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | Medi-Flex Hospital Products, Inc. | May 9, 1997 | SESE |
| K952947 | DELPORE SKIN CLOSURE | Bitco Intl. | Jul 24, 1995 | SESE |
| K952702 | DERMA SEAL | Ttl Medical | Jun 28, 1995 | SESE |
| K946321 | BIOSTRIP STERILE WOUND CLOSURE STRIP | Cornelia Damsky, Inc. | Jan 12, 1995 | SESE |
| K931005 | DUKAL SKIN CLOSURE STRIP | Dukal Corp. | Jul 14, 1993 | SESE |
| K921775 | SPYROFLEX WOUND CLOSURES | Polymint Industrial Co. , Ltd. | May 19, 1992 | SESE |
| K894802 | AWC BUTTERFLY WOUND CLOSURES | American White Cross, Inc. | Jan 31, 1990 | SESE |
| K894205 | TECNOL SILK STRIP | Tecnol New Jersey Wound Care, Inc. | Jul 25, 1989 | SESE |
| K874813 | OMED WOUND CLOSURE STRIPS | Oxboro Medical Intl., Inc. | Jan 29, 1988 | SESE |
| K840945 | SKIN CLOSURE | Gainor Medical | Oct 31, 1984 | SESE |
| K842621 | SUTURE STRIP | Genetic Laboratories, Inc. | Oct 25, 1984 | SESE |
| K833258 | SKIN TECH. SURGI-STRIPS | Lee Tec Corp. | Jan 25, 1984 | SESE |
| K833083 | DERMA STRIP-TM SKIN CLOSURES | Howmedica Corp. | Dec 30, 1983 | SESE |
| K831438 | ELASTOPLAST | Beiersdorf, Inc. | Nov 25, 1983 | SESE |
| K831439 | ELASTOPLAST T.P.N. | Beiersdorf, Inc. | Sep 29, 1983 | SESE |
| K821763 | SHUR-STRIP APPLICATOR | Shur Medical Corp. | Jun 23, 1982 | SESE |
| K802385 | CUSTOM DRESSING TRAY-WET TO DRY/MASS. | American Medical Disposable, Inc. | Nov 12, 1980 | SESE |
| K802384 | CENTRAL VENOUS CATHETER DRESSING TRAY | American Medical Disposable, Inc. | Nov 12, 1980 | SESE |
| K801837 | PLASTIC STRIP BANDAGES | Martin'S Maine Exchange | Oct 31, 1980 | SESE |
| K801884 | OP-SITE SKIN CLOSURE SUTURE ADHESIVE | Acme United Corp. | Oct 10, 1980 | SESE |
Top Applicants
- Johnson & Johnson Professionals, Inc. — 7 clearances
- Beiersdorf, Inc. — 6 clearances
- American Medical Disposable, Inc. — 2 clearances
- Shur Medical Corp. — 2 clearances
- Abbott Laboratories — 1 clearance
