FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPE
K Number: K921883
·
Decision Nov 23, 1992
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
17
Applicant Total
15
Review Days
216
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Basic Information
- Device Name
- ENDOSCOPE
- K Number
- K921883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optimed Technologies, Inc.
- Date Received
- April 21, 1992
- Decision Date
- November 23, 1992
- 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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
·Gastroenterology, Urology
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Optimed Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972520 | OPTIVIEW | Sep 29, 1997 | Substantially Equivalent |
| K955275 | BOOSTER TROPHY 5 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955276 | BOOSTER LITE 4 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955274 | BOOSTER LITE 3 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K943598 | FLEXIBLE FIBER OPTIC LAPAROSCOPES | Oct 18, 1994 | Substantially Equivalent |
| K926597 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Jul 12, 1994 | Substantially Equivalent |
| K921942 | HYSTEROSCOPE (AND ACCESSORIES) | Jun 24, 1994 | Substantially Equivalent |
| K922711 | FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE | May 17, 1994 | Substantially Equivalent |
| K921985 | ARTHROSCOPE & ACCESSORIES | Jun 29, 1993 | Substantially Equivalent |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Feb 19, 1993 | Substantially Equivalent |