FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILLIAMS OESOPHAGEAL VARICES INJECT TUBE
K Number: K810180
·
Decision Feb 9, 1981
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
29
Review Days
18
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
- WILLIAMS OESOPHAGEAL VARICES INJECT TUBE
- K Number
- K810180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Keymed, Inc.
- Date Received
- January 22, 1981
- Decision Date
- February 9, 1981
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FED), ordered by most recent decision date.
CVAC Aspiration System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Prodeon Urethral Sheath System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Suction-Evacuation Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single-use Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Keymed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | Apr 22, 2010 | Substantially Equivalent |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Mar 29, 1993 | Substantially Equivalent |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | May 12, 1988 | Substantially Equivalent |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | Feb 12, 1987 | Substantially Equivalent |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | Dec 24, 1986 | Substantially Equivalent |
| K862000 | KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Aug 12, 1986 | Substantially Equivalent |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | Jul 15, 1986 | Substantially Equivalent |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | Jun 23, 1986 | Substantially Equivalent |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | Jun 17, 1986 | Substantially Equivalent |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Nov 26, 1985 | Substantially Equivalent |