Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone
FDA 510(k) K080680 · Surgical Specialties Corp
510(k) numberK080680
Submission
- Device name
- Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone
- Applicant
- Surgical Specialties Corp
Herndon, VA, US - Received
- March 10, 2008
- Decision date
- March 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEW – Suture, Surgical, Absorbable, Polydioxanone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4840
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253879 | Monofix PdoNEW · Traditional | Samyang Holdings Corporation | 08/25/2026SE |
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special | Teleflex Medical, LLC | 07/09/2026SE |
| K252171 | Barbed PDO SutureNEW · Traditional | Sutura Medical Technology, Inc. | 06/12/2026SE |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional | ETHICON, Inc. | 05/18/2026SE |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional | ETHICON, Inc. | 11/12/2025SE |
| K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO)NEW · Traditional | Feeltech Co., Ltd. | 10/20/2025SE |
| K250107 | V-soft Line Barbed Surgical Suture (Various)NEW · Traditional | Feeltech Co., Ltd. | 10/15/2025SE |
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special | M/s. Meril Endo Surgery Private Limited. | 09/23/2025SE |
| K250977 | Suture-TOOL SystemNEW · Special | Suturion AB | 04/28/2025SE |
| K242835 | Suture-TOOL SystemNEW · Traditional | Suturion AB | 01/22/2025SE |
More from Suturion AB
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 |
| K053380 | Contour Thread Synthetic Absorbable Pdo Barbed SutureNEW · Traditional | 01/18/2006SE |
Questions and answers
When was Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone cleared by the FDA?
Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone (K080680) received a 510(k) decision of Substantially Equivalent on March 21, 2008, 11 days after the submission was received.
What is the product code of K080680?
The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.