G-Prox Endoscopic Grasper, Model 205333
FDA 510(k) K093018 · Usgi Medical
510(k) numberK093018
Submission
- Device name
- G-Prox Endoscopic Grasper, Model 205333
- Applicant
- Usgi Medical
San Clemente, CA, US - Received
- September 8, 2009
- Decision date
- October 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K103688 | G-Prox Ez Endoscopic GrasperOCZ · Special | 01/14/2011SE |
| K102931 | G-Cinch Suture GrasperOCW · Traditional | 12/30/2010SE |
| K102916 | G-Cath Tissue Anchor Delivery CatheterGAT · Special | 10/20/2010SE |
| K100251 | G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333GAT · Special | 02/17/2010SE |
| K072405 | Usgi Transport Endoscopic Access DeviceFED · Special | 09/13/2007SE |
| K061276 | G-Prox Endoscopic GrasperGAT · Traditional | 12/06/2006SE |
| K061268 | G-Lix Tissue GrasperHET · Traditional | 07/31/2006SE |
| K061216 | Usgi Transport Endoscopic GuideFED · Special | 05/15/2006SE |
| K051919 | Modification to: Usgi Shapelock Endoscopic GuideFED · Special | 07/26/2005SE |
| K050253 | Usgi Shapelock Endoscopic GuideFED · Special | 02/28/2005SE |
Questions and answers
When was G-Prox Endoscopic Grasper, Model 205333 cleared by the FDA?
G-Prox Endoscopic Grasper, Model 205333 (K093018) received a 510(k) decision of Substantially Equivalent on October 7, 2009, 29 days after the submission was received.
What is the product code of K093018?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.