Contour Midface Opposing Uni-Directional Threads
FDA 510(k) K050548 · Surgical Specialties Corp
510(k) numberK050548
Submission
- Device name
- Contour Midface Opposing Uni-Directional Threads
- Applicant
- Surgical Specialties Corp
Reading, PA, US - Received
- March 2, 2005
- Decision date
- April 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
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| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
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| 510(k) | Device | Decision |
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| K160744 | LOOK PTFE SutureNBY · Traditional | 07/13/2016SE |
| K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Special | 07/30/2014SE |
| K141625 | Polysyn Surgical SutureGAM · Special | 07/18/2014SE |
| K141558 | Quill Monoderm Knotless Tissue-Closure DeviceGAM · Special | 07/11/2014SE |
| K140227 | Monoderm Surgical SutureGAM · Special | 02/28/2014SE |
| K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)NEW · Special | 04/23/2008SE |
| K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneNEW · Special | 03/21/2008SE |
| K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialNEW · Traditional | 08/06/2007SE |
| K072028 | Quill Self-Retaining System (SRS) Comprised of MonodermGAM · Traditional | 08/03/2007SE |
| K063680 | Sharpoint Pdo (Polydioxanone) SuturesNEW · Traditional | 05/09/2007SE |
Questions and answers
When was Contour Midface Opposing Uni-Directional Threads cleared by the FDA?
Contour Midface Opposing Uni-Directional Threads (K050548) received a 510(k) decision of Substantially Equivalent on April 1, 2005, 30 days after the submission was received.
What is the product code of K050548?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.