FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HMT ENDOSCREEN, MODEL ESC 501
K Number: K942155
·
Decision Jul 1, 1994
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
3
Review Days
59
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
- HMT ENDOSCREEN, MODEL ESC 501
- K Number
- K942155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Servicetrends, Inc.
- Date Received
- May 3, 1994
- Decision Date
- July 1, 1994
- Product Code
- FCW
- 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 |
|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCW), ordered by most recent decision date.
NOVAPROBE LED LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWER LED 175
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OVS1 VIDEO SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LED LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology