DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
FDA 510(k) clearance K990090 · decided 1999-03-22
Clearance details
- K-number
- K990090
- Device name
- DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-11
- Decision date
- 1999-03-22
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- GAR
- Device class
- 2
- Regulation number
- 878.5020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| REXLON, REXSIL (K161633) | Sm Eng Co., Ltd. | 2017-03-02 |
| Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (K151165) | Aesculap, Inc. | 2016-02-17 |
| RiverLon (Nylon) Suture (K152795) | Riverpoint Medical | 2015-10-28 |
| VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (K123034) | Unilene Sac | 2013-05-28 |
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| FSSB NYLON SURGICAL SUTURES (K060471) | Fssb Chirurgische Nadeln GmbH | 2006-07-26 |
| MANI NEEDLE & SUTURE PACK (NYLON) (K053637) | Mani, Inc. | 2006-05-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgi recall (Z-2024-2014) | Aesculap, Inc. | 2014-07-09 |