SUTURELESS SKIN CLOSURE
FDA 510(k) clearance K780565 · decided 1978-07-07
Clearance details
- K-number
- K780565
- Device name
- SUTURELESS SKIN CLOSURE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1978-04-06
- Decision date
- 1978-07-07
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- FPX
- Device class
- 1
- Regulation number
- 880.5240
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Abbott Park, 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |