PDS PLUS ANTIBACTERIAL SUTURE
FDA 510(k) clearance K061037 · decided 2006-07-14
Clearance details
- K-number
- K061037
- Device name
- PDS PLUS ANTIBACTERIAL SUTURE
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-14
- Decision date
- 2006-07-14
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerville, NJ, 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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue ap recall (Z-2147-2024) | Ethicon, Inc. | 2024-06-14 |
| PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC- recall (Z-1571-2023) | Ethicon, Inc. | 2023-05-10 |
| PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue recall (Z-1314-2009) | Ethicon, Inc. | 2009-05-12 |
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 |