OP-SITE SKIN CLOSURE SUTURE ADHESIVE
FDA 510(k) clearance K801884 · decided 1980-10-10
Clearance details
- K-number
- K801884
- Device name
- OP-SITE SKIN CLOSURE SUTURE ADHESIVE
- Applicant
- Acme United Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-07
- Decision date
- 1980-10-10
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FPX
- Device class
- 1
- Regulation number
- 880.5240
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.