FSSB NYLON SURGICAL SUTURES
FDA 510(k) clearance K060471 · decided 2006-07-26
Clearance details
- K-number
- K060471
- Device name
- FSSB NYLON SURGICAL SUTURES
- Applicant
- Fssb Chirurgische Nadeln GmbH
- Decision
- Substantially Equivalent
- Date received
- 2006-02-23
- Decision date
- 2006-07-26
- Days to decision
- 153 days
- Clearance type
- Abbreviated
- Product code
- GAR
- Device class
- 2
- Regulation number
- 878.5020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| Non Absorbable Surgical Nylon Suture (K212603) | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 |
| Crownjun Nylon Suture (K192420) | Kono Seisakusho Co., Ltd. | 2020-05-29 |
| 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 |
| KUMAR T-ANCHORS HERNIA SET (K081366) | Nashville Surgical Instruments | 2008-07-15 |
| MANI NEEDLE & SUTURE PACK (NYLON) (K053637) | Mani, Inc. | 2006-05-19 |
| AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE (K060528) | Aesculap, Inc. | 2006-03-28 |
Recalls involving this device
No recalls on record reference this clearance.