FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTEROSCOPE
K Number: K840722
·
Decision Jun 7, 1984
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
19
Applicant Total
58
Review Days
111
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Basic Information
- Device Name
- ENTEROSCOPE
- K Number
- K840722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Trimedyne, Inc.
- Date Received
- February 17, 1984
- Decision Date
- June 7, 1984
- Product Code
- FDA
- 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 |
|---|---|---|---|
| FDA | Enteroscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | Dec 20, 2000 | Substantially Equivalent |
| K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | Nov 2, 2000 | Substantially Equivalent |
| K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A | Oct 29, 1999 | Substantially Equivalent |
| K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP | Jul 12, 1999 | Substantially Equivalent |