GYNECOLOGICAL CYSTO/URETHROSCOPE
FDA 510(k) clearance K800913 · decided 1980-05-14
Clearance details
- K-number
- K800913
- Device name
- GYNECOLOGICAL CYSTO/URETHROSCOPE
- Applicant
- Kli
- Decision
- Substantially Equivalent
- Date received
- 1980-04-21
- Decision date
- 1980-05-14
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- FGC
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIRECTVISION GUIDE SYSTEM (K091600) | Percuvision, LLC | 2009-08-25 |
| KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES (K945907) | KARL STORZ Endoscopy-America, Inc. | 1995-05-12 |
Recalls involving this device
No recalls on record reference this clearance.