GS-4000 Reducer Sleeve, 11MM to 5MM
FDA 510(k) K900955 · Solos Endoscopy, Inc.
510(k) numberK900955
Submission
- Device name
- GS-4000 Reducer Sleeve, 11MM to 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
- FBM – Cannula And Trocar, Suprapubic, Non-Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…FBM · Traditional | Snowden-Pencer | 03/12/1996SE |
| K932021 | Entree Cannula Fascia AnchorsFBM · Traditional | Core Dynamics, Inc. | 01/11/1994SE |
| K911813 | Entree CannulaFBM · Traditional | Core Dynamics, Inc. | 07/19/1991SE |
| K900965 | GS-4550 Trocar Only, 11MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900964 | Cannula and Trocar, 11MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900963 | GS-4350 Trocar Only, 5.5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900962 | GS-4300 Cannula and Trocar, 5.5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900961 | GS-4100 Reducer Sleeve, 5MM to 3MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
More from Solos Endoscopy, 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-4000 Reducer Sleeve, 11MM to 5MM cleared by the FDA?
GS-4000 Reducer Sleeve, 11MM to 5MM (K900955) 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 K900955?
The FDA product code is FBM – Cannula And Trocar, Suprapubic, Non-Disposable, a Class I (low risk) device regulated under 21 CFR 876.5090.