Product code FPX
- Device name
- Strip, Adhesive, Closure, Skin
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5240
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970441 | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | Medi-Flex Hospital Products, Inc. | 1997-05-09 |
| K952947 | DELPORE SKIN CLOSURE | Bitco Intl. | 1995-07-24 |
| K952702 | DERMA SEAL | Ttl Medical | 1995-06-28 |
| K946321 | BIOSTRIP STERILE WOUND CLOSURE STRIP | Cornelia Damsky, Inc. | 1995-01-12 |
| K931005 | DUKAL SKIN CLOSURE STRIP | Dukal Corp. | 1993-07-14 |
| K921775 | SPYROFLEX WOUND CLOSURES | Polymint Industrial Co. , Ltd. | 1992-05-19 |
| K894802 | AWC BUTTERFLY WOUND CLOSURES | American White Cross, Inc. | 1990-01-31 |
| K894205 | TECNOL SILK STRIP | Tecnol New Jersey Wound Care, Inc. | 1989-07-25 |
| K874813 | OMED WOUND CLOSURE STRIPS | Oxboro Medical Intl., Inc. | 1988-01-29 |
| K840945 | SKIN CLOSURE | Gainor Medical | 1984-10-31 |
| K842621 | SUTURE STRIP | Genetic Laboratories, Inc. | 1984-10-25 |
| K833258 | SKIN TECH. SURGI-STRIPS | Lee Tec Corp. | 1984-01-25 |
| K833083 | DERMA STRIP-TM SKIN CLOSURES | Howmedica Corp. | 1983-12-30 |
| K831438 | ELASTOPLAST | Beiersdorf, Inc. | 1983-11-25 |
| K831439 | ELASTOPLAST T.P.N. | Beiersdorf, Inc. | 1983-09-29 |
| K821763 | SHUR-STRIP APPLICATOR | Shur Medical Corp. | 1982-06-23 |
| K802384 | CENTRAL VENOUS CATHETER DRESSING TRAY | American Medical Disposable, Inc. | 1980-11-12 |
| K802385 | CUSTOM DRESSING TRAY-WET TO DRY/MASS. | American Medical Disposable, Inc. | 1980-11-12 |
| K801837 | PLASTIC STRIP BANDAGES | Martin'S Maine Exchange | 1980-10-31 |
| K801884 | OP-SITE SKIN CLOSURE SUTURE ADHESIVE | Acme United Corp. | 1980-10-10 |
| K792725 | FIXOMULL | Beiersdorf, Inc. | 1980-03-05 |
| K792726 | LEUKOFIX POROS | Beiersdorf, Inc. | 1980-02-28 |
| K792667 | LEUKOCLIP POROS | Beiersdorf, Inc. | 1980-01-16 |
| K792136 | HYPO-ALLERGENIC PLASTIC TAPE | National Patent Development Corp. | 1980-01-16 |
| K792360 | HANSAPOR STERILE | Beiersdorf, Inc. | 1979-12-31 |
| K790140 | SKIN CLOSURE TAPES STERILE | Shur Medical Corp. | 1979-02-27 |
| K782003 | BAND AID* ADHESIVE BANDAGES | Johnson & Johnson Professionals, Inc. | 1979-01-17 |
| K781952 | PAPER TAPE, HYPO ALLERGENIC | Johnson & Johnson Professionals, Inc. | 1978-12-07 |
| K780565 | SUTURELESS SKIN CLOSURE | Abbott Laboratories | 1978-07-07 |
| K772020 | CLOTH ADHESIVE TAPE | Johnson & Johnson Professionals, Inc. | 1977-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30197344203530 | CURAD | MEDLINE INDUSTRIES, INC. | 2026-05-15 |
| 00194346192038 | Equate | WAL-MART STORES, INC. | 2024-02-15 |
| 00017276239287 | Care Science | Aso LLC | 2023-06-08 |
| 10665973008858 | Dukal | Dukal LLC | 2022-12-06 |
| 10665973008841 | Dukal | Dukal LLC | 2022-12-06 |
| 10665973008803 | Dukal | Dukal LLC | 2022-12-06 |
| 10665973008810 | Dukal | Dukal LLC | 2022-12-06 |
| 10665973008827 | Dukal | Dukal LLC | 2022-12-06 |
| 10665973008834 | Dukal | Dukal LLC | 2022-12-06 |
| H65890043151 | Henry Schein | HENRY SCHEIN, INC. | 2021-07-22 |
| H65890043181 | Henry Schein | HENRY SCHEIN, INC. | 2021-07-22 |
| H65890075061 | Henry Schein | HENRY SCHEIN, INC. | 2021-07-22 |
| H65890043141 | Henry Schein | HENRY SCHEIN, INC. | 2021-07-22 |
| H65890043171 | Henry Schein | HENRY SCHEIN, INC. | 2021-07-22 |
| H65890043161 | Henry Schein | HENRY SCHEIN, INC. | 2021-07-22 |
| 00311917143354 | Walgreens | WALGREEN CO. | 2020-02-28 |
| 00050428288467 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2020-02-28 |
| 00041520089410 | CareOne | Ahold U.S.A., Inc. | 2019-07-31 |
| 10753567331045 | Suture Strip® | Derma Sciences Canada Inc | 2019-03-14 |
| 10753567331038 | Suture Strip® | Derma Sciences Canada Inc | 2019-03-14 |
| 10753567331021 | Suture Strip® | Derma Sciences Canada Inc | 2019-03-14 |
| 00809958000083 | Suture Strip® | Derma Sciences Canada Inc | 2018-10-23 |
| 00809958000113 | Suture Strip® | Derma Sciences Canada Inc | 2018-10-23 |
| 00614950009152 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2017-07-05 |
| 00614950008797 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2017-02-24 |
| 00614950008803 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2017-02-24 |
| 00614950008810 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2017-02-24 |
| 00614950008827 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2017-02-24 |
| 00614950008834 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2017-02-24 |
| 00614950008841 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2017-02-24 |