Strip, Adhesive, Closure, Skin
FDA product code FPX · Class I (low risk) · 21 CFR 880.5240 · General Hospital
35510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Johnson & Johnson Professionals, Inc. 7
- Beiersdorf, Inc. 6
- Shur Medical Corp. 2
- American Medical Disposable, Inc. 2
- Lee Tec Corp. 1
- Medi-Flex Hospital Products, Inc. 1
- Ttl Medical 1
- Cornelia Damsky, Inc. 1
- Dukal Corp. 1
- Polymint Industrial Co. , Ltd. 1
- American White Cross, Inc. 1
- Tecnol New Jersey Wound Care, Inc. 1
- Oxboro Medical Intl., Inc. 1
- Gainor Medical 1
- Genetic Laboratories, Inc. 1
- Howmedica Corp. 1
- Martin'S Maine Exchange 1
- Acme United Corp. 1
- National Patent Development Corp. 1
- Abbott Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | Medi-Flex Hospital Products, Inc. | 05/09/1997SE |
| K952947 | Delpore Skin ClosureFPX · Traditional | Bitco Intl. | 07/24/1995SE |
| K952702 | Derma SealFPX · Traditional | Ttl Medical | 06/28/1995SE |
| K946321 | Biostrip Sterile Wound Closure StripFPX · Traditional | Cornelia Damsky, Inc. | 01/12/1995SE |
| K931005 | Dukal Skin Closure StripFPX · Traditional | Dukal Corp. | 07/14/1993SE |
| K921775 | Spyroflex Wound ClosuresFPX · Traditional | Polymint Industrial Co. , Ltd. | 05/19/1992SE |
| K894802 | Awc Butterfly Wound ClosuresFPX · Traditional | American White Cross, Inc. | 01/31/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | Tecnol New Jersey Wound Care, Inc. | 07/25/1989SE |
| K874813 | Omed Wound Closure StripsFPX · Traditional | Oxboro Medical Intl., Inc. | 01/29/1988SE |
| K840945 | Skin ClosureFPX · Traditional | Gainor Medical | 10/31/1984SE |
| K842621 | Suture StripFPX · Traditional | Genetic Laboratories, Inc. | 10/25/1984SE |
| K833258 | Skin Tech. Surgi-StripsFPX · Traditional | Lee Tec Corp. | 01/25/1984SE |
| K833083 | Derma Strip-Tm Skin ClosuresFPX · Traditional | Howmedica Corp. | 12/30/1983SE |
| K831438 | ElastoplastFPX · Traditional | Beiersdorf, Inc. | 11/25/1983SE |
| K831439 | Elastoplast T.P.N.FPX · Traditional | Beiersdorf, Inc. | 09/29/1983SE |
| K821763 | Shur-Strip ApplicatorFPX · Traditional | Shur Medical Corp. | 06/23/1982SE |
| K802385 | Custom Dressing Tray-Wet to Dry/Mass.FPX · Traditional | American Medical Disposable, Inc. | 11/12/1980SE |
| K802384 | Central Venous Catheter Dressing TrayFPX · Traditional | American Medical Disposable, Inc. | 11/12/1980SE |
| K801837 | Plastic Strip BandagesFPX · Traditional | Martin'S Maine Exchange | 10/31/1980SE |
| K801884 | Op-Site Skin Closure Suture AdhesiveFPX · Traditional | Acme United Corp. | 10/10/1980SE |
| K792725 | FixomullFPX · Traditional | Beiersdorf, Inc. | 03/05/1980SE |
| K792726 | Leukofix PorosFPX · Traditional | Beiersdorf, Inc. | 02/28/1980SE |
| K792667 | Leukoclip PorosFPX · Traditional | Beiersdorf, Inc. | 01/16/1980SE |
| K792136 | Hypo-Allergenic Plastic TapeFPX · Traditional | National Patent Development Corp. | 01/16/1980SE |
| K792360 | Hansapor SterileFPX · Traditional | Beiersdorf, Inc. | 12/31/1979SE |
| K790140 | Skin Closure Tapes SterileFPX · Traditional | Shur Medical Corp. | 02/27/1979SE |
| K782003 | Band Aid* Adhesive BandagesFPX · Traditional | Johnson & Johnson Professionals, Inc. | 01/17/1979SE |
| K781952 | Paper Tape, Hypo AllergenicFPX · Traditional | Johnson & Johnson Professionals, Inc. | 12/07/1978SE |
| K780565 | Sutureless Skin ClosureFPX · Traditional | Abbott Laboratories | 07/07/1978SE |
| K772020 | Cloth Adhesive TapeFPX · Traditional | Johnson & Johnson Professionals, Inc. | 11/02/1977SE |
| K771125 | Polyurethane Prod. for I.V. NeedlesFPX · Traditional | Devon Industries, Inc. | 08/02/1977SE |
| K770533 | Band-Aid Brand Adhes. Band.-Sheer StripsFPX · Traditional | Johnson & Johnson Professionals, Inc. | 06/07/1977SE |
| K770081 | Band-Aid Brand of Adhesive BandagesFPX · Traditional | Johnson & Johnson Professionals, Inc. | 03/09/1977SE |
| K770339 | Bandage, Plastic & SheerFPX · Traditional | Johnson & Johnson Professionals, Inc. | 02/28/1977SE |
| K770180 | Sub. of Diacetone AcrylamideFPX · Traditional | Johnson & Johnson Professionals, Inc. | 02/15/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1988-2013 Class II | Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free…Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling… | Aspen Surgical Products, Inc. | 07/18/2013Terminated |