Dafilon Nonabsorbable Polyamide Surgical Suture
FDA 510(k) K990090 · Aesculap, Inc.
510(k) numberK990090
Submission
- Device name
- Dafilon Nonabsorbable Polyamide Surgical Suture
- Applicant
- Aesculap, Inc.
San Diego, CA, US - Received
- January 11, 1999
- Decision date
- March 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAR – Suture, Nonabsorbable, Synthetic, Polyamide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5020
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K192420 | Crownjun Nylon SutureGAR · Traditional | Kono Seisakusho Co., Ltd. | 05/29/2020SE |
| K161633 | Rexlon, RexsilGAR · Traditional | Sm Eng Co., Ltd. | 03/02/2017SE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | Aesculap, Inc. | 02/17/2016SE |
| K152795 | RiverLon (Nylon) SutureGAR · Special | Riverpoint Medical | 10/28/2015SE |
| K123034 | Vital Sutures Suturex Cirugia Peruana SutumedGAR · Traditional | Unilene Sac | 05/28/2013SE |
| K081366 | Kumar T-Anchors Hernia SetGAR · Traditional | Nashville Surgical Instruments | 07/15/2008SE |
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Questions and answers
When was Dafilon Nonabsorbable Polyamide Surgical Suture cleared by the FDA?
Dafilon Nonabsorbable Polyamide Surgical Suture (K990090) received a 510(k) decision of Substantially Equivalent on March 22, 1999, 70 days after the submission was received.
What is the product code of K990090?
The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.