GS-7000 Clip-Applying Forcep, 10MM, Medium Clip
FDA 510(k) K900951 · Solos Endoscopy, Inc.
510(k) numberK900951
Submission
- Device name
- GS-7000 Clip-Applying Forcep, 10MM, Medium Clip
- 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
- GEN – Forceps, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031828 | Naturalase LP Nd:Yag LaserGEN · Traditional | Focus Medical, LLC | 07/17/2003SE |
| K953962 | ForcepsGEN · Traditional | Biopsys Medical, Inc. | 09/08/1995SE |
| K932385 | Suture Removing ForcepsGEN · Traditional | Rocket of London, Ltd. | 08/06/1993SE |
| K904723 | ForcepsGEN · Traditional | Minto Research & Development, Inc. | 07/26/1991SE |
| K911159 | Palpation ProbeGEN · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K900960 | GS-1500 Claw Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900952 | GS-1200 Grasping/Extracting Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900948 | GS-1002 Grasping Forcep, 5MM with RatchetGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K891896 | Tissue Forceps, Various TypesGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891401 | Hemostatic Forceps Bruns.,Gemini,Spencer-Well,KantGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/06/1989SE |
More from Zinnanti Surgical Instruments, 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-7000 Clip-Applying Forcep, 10MM, Medium Clip cleared by the FDA?
GS-7000 Clip-Applying Forcep, 10MM, Medium Clip (K900951) 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 K900951?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.