ETHICON NONABSORBABLE SUTURE ANCHOR
FDA 510(k) clearance K943950 · decided 1995-05-30
Clearance details
- K-number
- K943950
- Device name
- ETHICON NONABSORBABLE SUTURE ANCHOR
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-08-15
- Decision date
- 1995-05-30
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- JDR
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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| TMC Compression Implant System (K242415) | Treace Medical Concepts | 2024-09-06 |
| COGNiTiON™ Staple System (K240212) | Ortho Solutions UK , Ltd. | 2024-02-23 |
| A’TOMIC™ Nitinol Fixation System (K232990) | Rmr Ortho, LLC | 2024-01-12 |
| arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (K230724) | Novastep | 2023-12-04 |
| Medline UNITE® REFLEX® Nitinol Staple Kit (K232905) | Medline Industries, LP | 2023-10-19 |
| StealthFix Intraosseous Fixation System (K232324) | Medartis, Inc. | 2023-08-30 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |