GS-1400 Toothed Dissecting Forcep, 5MM, Insulated
FDA 510(k) K900959 · Solos Endoscopy, Inc.
510(k) numberK900959
Submission
- Device name
- GS-1400 Toothed Dissecting Forcep, 5MM, Insulated
- Applicant
- Solos Endoscopy, Inc.
Norcross, GA, US - Received
- February 27, 1990
- Decision date
- April 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEJ – Carrier, Ligature
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240185 | Cypris eXact Suture Placement DeviceGEJ · Traditional | Cypris Medical | 05/03/2024SE |
| K900958 | GS-1300 Atraumatic Grasping Forcep, Curved, 10MMGEJ · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K884553 | Stamey NeedleGEJ · Traditional | Cook Ob/Gyn | 11/14/1988SE |
| K874342 | Ligature Carrier/Packer, HydroxylapatiteGEJ · Traditional | Cox-Uphuff Intl. | 11/13/1987SE |
More from Cox-Uphuff Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K983538 | Miniaturized Biopsy,Scope A.K.A: Biopsy Needle with Endoscopic Viewing CapabilityGCJ · Special | 11/06/1998SE |
| K910671 | Model GS-4700 Common Duct Stone Removing KitFGE · Traditional | 05/10/1991SE |
| K900965 | GS-4550 Trocar Only, 11MMFBM · Traditional | 04/18/1990SE |
| K900964 | Cannula and Trocar, 11MMFBM · Traditional | 04/18/1990SE |
| K900963 | GS-4350 Trocar Only, 5.5MMFBM · Traditional | 04/18/1990SE |
| K900962 | GS-4300 Cannula and Trocar, 5.5MMFBM · Traditional | 04/18/1990SE |
| K900961 | GS-4100 Reducer Sleeve, 5MM to 3MMFBM · Traditional | 04/18/1990SE |
| K900960 | GS-1500 Claw Forcep, 10MMGEN · Traditional | 04/18/1990SE |
| K900958 | GS-1300 Atraumatic Grasping Forcep, Curved, 10MMGEJ · Traditional | 04/18/1990SE |
| K900957 | GS-2100 Hook Suture Scissor, 5MMLRW · Traditional | 04/18/1990SE |
Questions and answers
When was GS-1400 Toothed Dissecting Forcep, 5MM, Insulated cleared by the FDA?
GS-1400 Toothed Dissecting Forcep, 5MM, Insulated (K900959) received a 510(k) decision of Substantially Equivalent on April 18, 1990, 50 days after the submission was received.
What is the product code of K900959?
The FDA product code is GEJ – Carrier, Ligature, a Class I (low risk) device regulated under 21 CFR 878.4800.