FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIGID FIBEROPITC ENDOSCOPE
K Number: K844769
·
Decision Jan 15, 1985
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
17
Applicant Total
18
Review Days
39
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Basic Information
- Device Name
- RIGID FIBEROPITC ENDOSCOPE
- K Number
- K844769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Microvasive
- Date Received
- December 7, 1984
- Decision Date
- January 15, 1985
- Product Code
- GCM
- 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 |
|---|---|---|---|
| GCM | Endoscope, Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCM), ordered by most recent decision date.
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
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MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
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INSIDE VIEW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OMNISONIC ENDOSCOPIC DEFLECTOR
FDA 510(k)
FDA Class 2
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KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Microvasive
| K Number | Device Name | ||
|---|---|---|---|
| K872771 | LOW PROFILE GASTROSTOMY | Oct 9, 1987 | Substantially Equivalent |
| K870705 | THERMAL COAGULATOR | Apr 17, 1987 | Substantially Equivalent |
| K861309 | JEJUNAL FEEDING TUBE | Dec 16, 1986 | Substantially Equivalent |
| K861323 | REPLACEMENT GASTROSTOMY TUBE | Dec 16, 1986 | Substantially Equivalent |
| K860589 | INFLATOR/DEFLATOR PISTON SYRINGE | Apr 7, 1986 | Substantially Equivalent |
| K860366 | CHALLENGER HOT BIOPSY FORCEPS | Apr 7, 1986 | Substantially Equivalent |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | Nov 13, 1985 | Substantially Equivalent |
| K854063 | MICROVASIVE SILICONE SPRAY | Oct 25, 1985 | Substantially Equivalent |
| K851652 | PAPILLOTOME | Jun 24, 1985 | Substantially Equivalent |
| K850393 | FLEXIBLE FIBEROPTIC ENDOSCOPE | Jun 4, 1985 | Substantially Equivalent |