Surgical Specialties Corp
Medical device manufacturer in Westwood, MA.
33510(k) clearances
0PMA approvals
3recalls
Device types
- GAM Suture, Absorbable, Synthetic, Polyglycolic… 8
- GAW Suture, Nonabsorbable, Synthetic… 5
- NEW Suture, Surgical, Absorbable, Polydioxanone 5
- EFQ Gauze/Sponge, Internal 4
- GAP Suture, Nonabsorbable, Silk 2
- FRO Dressing, Wound, Drug 1
- GAR Suture, Nonabsorbable, Synthetic, Polyamide 1
- GAT Suture, Nonabsorbable, Synthetic… 1
- KXK Source, Brachytherapy, Radionuclide 1
- HNO Keratome, Ac-Powered 1
- GAN Suture, Absorbable, Synthetic 1
- LZU Plug, Punctum 1
- MTJ Wax, Bone 1
- NBY Suture, Surgical, Nonabsorbable, Expanded… 1
510(k) clearances
| 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 |
| 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 |
| K053380 | Contour Thread Synthetic Absorbable Pdo Barbed SutureNEW · Traditional | 01/18/2006SE |
| K052962 | Optimized Barb DesignGAW · Traditional | 12/06/2005SE |
| K052437 | Modified Monoderm Monofilament, Synthetic, Absorbable SutureGAM · Traditional | 11/07/2005SE |
| K050548 | Contour Midface Opposing Uni-Directional ThreadsGAW · Traditional | 04/01/2005SE |
| K050292 | Sharpoint Lukens Bone WaxMTJ · Traditional | 03/09/2005SE |
| K050247 | Contour Necklift ThreadsGAW · Traditional | 03/04/2005SE |
| K042856 | Contour Forehead/Browlift ThreadGAW · Traditional | 12/03/2004SE |
| K041593 | Featherlift Extended Length Aptos ThreadGAW · Traditional | 09/20/2004SE |
| K040477 | MonodermGAM · Traditional | 05/18/2004SE |
| K020882 | Sharpoint Ultraplug Extended Wear PlugLZU · Traditional | 07/26/2002SE |
| K014021 | Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, UndyedGAM · Traditional | 01/28/2002SE |
| K003015 | Ssc's PCL Monofilament SAS, Violet, Coated, Model TBDGAN · Traditional | 12/15/2000SE |
| K002849 | Precisionedge-Acc, Precisionedge-Acs, Precisionedge-Lsk, and Precisionedge-Cb…HNO · Traditional | 10/18/2000SE |
| K001765 | Look Collagen Spacers, Model 1514BKXK · Traditional | 09/07/2000SE |
| K932038 | Suture Nonabsorbable- Silk, PolyesterGAT · Traditional | 01/07/1994SE |
| K932037 | Suture Absorbable- GutGAR · Traditional | 01/07/1994SE |
| K930826 | Suture Nonabsorbable - SilkGAP · Traditional | 01/07/1994SE |
| K930825 | Suture Nonabsorbable-Nylon,Silk,Polyester,StainlesGAP · Traditional | 01/07/1994SE |
| K874219 | S3 Medicated GauzeFRO · Traditional | 11/23/1987SE |
| K861446 | S1 Oral PackingEFQ · Traditional | 05/06/1986SE |
| K861445 | S1 Cavity PackingEFQ · Traditional | 05/06/1986SE |
| K861444 | S1 Nasal PackingEFQ · Traditional | 05/06/1986SE |
| K861443 | S1 Vaginal PackingEFQ · Traditional | 05/06/1986SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1534-2024 Class II | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503NComplaints have been received with allegations of Incorrect Needle Curvature. | 03/26/2024Open, Classified |
| Z-2138-2011 | SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged…Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0… | 03/30/2011Terminated |
| Z-0034-2009 | 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended…mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture | 09/09/2008Terminated |