FPX
35 FDA 510(k) clearances · Product code
54 daysmedian time to decision
147 days90th percentile
35clearances measured
FDA profile
- Official device name
- Strip, Adhesive, Closure, Skin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 2 · 1996: 5 · 1997: 1 · 2009: 6 · 2010: 10 · 2011: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (K970441) | Medi-Flex Hospital Products, Inc. | 1997-05-09 |
| DELPORE SKIN CLOSURE (K952947) | Bitco Intl. | 1995-07-24 |
| DERMA SEAL (K952702) | Ttl Medical | 1995-06-28 |
| BIOSTRIP STERILE WOUND CLOSURE STRIP (K946321) | Cornelia Damsky, Inc. | 1995-01-12 |
| DUKAL SKIN CLOSURE STRIP (K931005) | Dukal Corp. | 1993-07-14 |
| SPYROFLEX WOUND CLOSURES (K921775) | Polymint Industrial Co. , Ltd. | 1992-05-19 |
| AWC BUTTERFLY WOUND CLOSURES (K894802) | American White Cross, Inc. | 1990-01-31 |
| TECNOL SILK STRIP (K894205) | Tecnol New Jersey Wound Care, Inc. | 1989-07-25 |
| OMED WOUND CLOSURE STRIPS (K874813) | Oxboro Medical Intl., Inc. | 1988-01-29 |
| SKIN CLOSURE (K840945) | Gainor Medical | 1984-10-31 |
| SUTURE STRIP (K842621) | Genetic Laboratories, Inc. | 1984-10-25 |
| SKIN TECH. SURGI-STRIPS (K833258) | Lee Tec Corp. | 1984-01-25 |
| DERMA STRIP-TM SKIN CLOSURES (K833083) | Howmedica Corp. | 1983-12-30 |
| ELASTOPLAST (K831438) | Beiersdorf, Inc. | 1983-11-25 |
| ELASTOPLAST T.P.N. (K831439) | Beiersdorf, Inc. | 1983-09-29 |
| SHUR-STRIP APPLICATOR (K821763) | Shur Medical Corp. | 1982-06-23 |
| CUSTOM DRESSING TRAY-WET TO DRY/MASS. (K802385) | American Medical Disposable, Inc. | 1980-11-12 |
| CENTRAL VENOUS CATHETER DRESSING TRAY (K802384) | American Medical Disposable, Inc. | 1980-11-12 |
| PLASTIC STRIP BANDAGES (K801837) | Martin'S Maine Exchange | 1980-10-31 |
| OP-SITE SKIN CLOSURE SUTURE ADHESIVE (K801884) | Acme United Corp. | 1980-10-10 |
| FIXOMULL (K792725) | Beiersdorf, Inc. | 1980-03-05 |
| LEUKOFIX POROS (K792726) | Beiersdorf, Inc. | 1980-02-28 |
| LEUKOCLIP POROS (K792667) | Beiersdorf, Inc. | 1980-01-16 |
| HYPO-ALLERGENIC PLASTIC TAPE (K792136) | National Patent Development Corp. | 1980-01-16 |
| HANSAPOR STERILE (K792360) | Beiersdorf, Inc. | 1979-12-31 |
| SKIN CLOSURE TAPES STERILE (K790140) | Shur Medical Corp. | 1979-02-27 |
| BAND AID* ADHESIVE BANDAGES (K782003) | Johnson & Johnson Professionals, Inc. | 1979-01-17 |
| PAPER TAPE, HYPO ALLERGENIC (K781952) | Johnson & Johnson Professionals, Inc. | 1978-12-07 |
| SUTURELESS SKIN CLOSURE (K780565) | Abbott Laboratories | 1978-07-07 |
| CLOTH ADHESIVE TAPE (K772020) | Johnson & Johnson Professionals, Inc. | 1977-11-02 |
| POLYURETHANE PROD. FOR I.V. NEEDLES (K771125) | Devon Industries, Inc. | 1977-08-02 |
| BAND-AID BRAND ADHES. BAND.-SHEER STRIPS (K770533) | Johnson & Johnson Professionals, Inc. | 1977-06-07 |
| BAND-AID BRAND OF ADHESIVE BANDAGES (K770081) | Johnson & Johnson Professionals, Inc. | 1977-03-09 |
| BANDAGE, PLASTIC & SHEER (K770339) | Johnson & Johnson Professionals, Inc. | 1977-02-28 |
| SUB. OF DIACETONE ACRYLAMIDE (K770180) | Johnson & Johnson Professionals, Inc. | 1977-02-15 |
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Every clearance here is in the API, with alerts when new ones post.