Surgical Stainless Steel Suture, Stainless Steel Suture
FDA 510(k) clearance K170767 · decided 2017-11-01
Clearance details
- K-number
- K170767
- Device name
- Surgical Stainless Steel Suture, Stainless Steel Suture
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-14
- Decision date
- 2017-11-01
- Days to decision
- 232 days
- Clearance type
- Special
- Product code
- GAQ
- Device class
- 2
- Regulation number
- 878.4495
- 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
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| ETHIZIA Hemostatic Patch (P240035/S005) | ETHICON, Inc. | 2026-02-26 |
| ETHIZIA Hemostatic Patch (P240035/S006) | ETHICON, Inc. | 2026-02-24 |
| ETHIZIA Hemostatic Patch (P240035/S003) | ETHICON, Inc. | 2026-01-28 |
| ETHIZIA Hemostatic Patch (P240035/S001) | ETHICON, Inc. | 2026-01-22 |