GS-2100 Hook Suture Scissor, 5MM
FDA 510(k) K900957 · Solos Endoscopy, Inc.
510(k) numberK900957
Submission
- Device name
- GS-2100 Hook Suture Scissor, 5MM
- 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
- LRW – Scissors, General, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LRW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911158 | Micro Scissors, 5MM Curve Micro Scissors, 5MMLRW · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K902828 | Suture Removal TrayLRW · Traditional | Orion Life Systems, Inc. | 08/08/1990SEKD |
| K900950 | GS-2000 Micro Scissor, Curved Left, 5MMLRW · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K892823 | Plaster Cutting ScissorsLRW · Traditional | The South India Surgical Co. Pvt. , Ltd. | 05/25/1989SE |
| K891889 | Olivecorona ScissorsLRW · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891886 | Scissors, Various TypesLRW · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891203 | Scissors: Thorek, Jorgensen, FinochiettoLRW · Traditional | Zinnanti Surgical Instruments, Inc. | 04/06/1989SE |
| K891200 | Ribbon Type Scissors: Tenotomy,Iris,Eye,StrabismusLRW · Traditional | Zinnanti Surgical Instruments, Inc. | 04/06/1989SE |
| K890235 | Dressing ScissorsLRW · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890170 | ScissorsLRW · Traditional | Dhason Brothers, Inc. | 02/03/1989SE |
More from Dhason Brothers, Inc.
| 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 |
| K900959 | GS-1400 Toothed Dissecting Forcep, 5MM, InsulatedGEJ · Traditional | 04/18/1990SE |
| K900958 | GS-1300 Atraumatic Grasping Forcep, Curved, 10MMGEJ · Traditional | 04/18/1990SE |
Questions and answers
When was GS-2100 Hook Suture Scissor, 5MM cleared by the FDA?
GS-2100 Hook Suture Scissor, 5MM (K900957) 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 K900957?
The FDA product code is LRW – Scissors, General, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.