FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
K Number: K910671
·
Decision May 10, 1991
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
21
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
- K Number
- K910671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Solos Endoscopy, Inc.
- Date Received
- February 15, 1991
- Decision Date
- May 10, 1991
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGE), ordered by most recent decision date.
Dilation Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoflux Biliary & Pancreatic Stent Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BARE Wireguided Balloon Dilation Catheter (1235)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single use stone retrieval balloons
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Solos Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983538 | MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY | Nov 6, 1998 | Substantially Equivalent |
| K900964 | CANNULA AND TROCAR, 11MM | Apr 18, 1990 | Substantially Equivalent |
| K900959 | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | Apr 18, 1990 | Substantially Equivalent |
| K900957 | GS-2100 HOOK SUTURE SCISSOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900965 | GS-4550 TROCAR ONLY, 11MM | Apr 18, 1990 | Substantially Equivalent |
| K900954 | GS-5200 HOOK SUCTION/COAGULATOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Apr 18, 1990 | Substantially Equivalent |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Apr 18, 1990 | Substantially Equivalent |
| K900953 | GS-5000 SPATULA SUCTION/COAGULATOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Apr 18, 1990 | Substantially Equivalent |