FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYNECOLOGICAL CYSTO/URETHROSCOPE
K Number: K800913
·
Decision May 14, 1980
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
2
Applicant Total
18
Review Days
23
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Basic Information
- Device Name
- GYNECOLOGICAL CYSTO/URETHROSCOPE
- K Number
- K800913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Kli
- Date Received
- April 21, 1980
- Decision Date
- May 14, 1980
- Product Code
- FGC
- 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 |
|---|---|---|---|
| FGC | Urethroscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGC), ordered by most recent decision date.
DIRECTVISION GUIDE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Kli
| K Number | Device Name | ||
|---|---|---|---|
| K800822 | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE | Jun 17, 1980 | Substantially Equivalent |
| K781913 | INSUFFALATOR LAPARAOSCOPIC | Dec 4, 1978 | Substantially Equivalent |
| K781109 | FORCEPS, ELECTROSURGICAL | Sep 14, 1978 | Substantially Equivalent |
| K781089 | ONE INCISION BI-POLAR ELECTRO. FORCEPS | Jul 17, 1978 | Substantially Equivalent |
| K780955 | SCISSORS, HOOK, ELECTROSURGICAL | Jun 22, 1978 | Substantially Equivalent |
| K780954 | SCISSORS, HOOK, ELECTROSURGICAL | Jun 22, 1978 | Substantially Equivalent |
| K772297 | INSUFFLATOR, MODEL G100 & 200 | Jan 5, 1978 | Substantially Equivalent |
| K772242 | LAPAROSCOPY CONSOLE MODEL VIII | Dec 20, 1977 | Substantially Equivalent |
| K772220 | PROBE, COAGULATION ACCESSORY | Dec 13, 1977 | Substantially Equivalent |
| K772185 | LAPAROSCOPE W/REMOVABLE OPTICS | Nov 30, 1977 | Substantially Equivalent |