KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS— 510(k) K950976
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K950976 for KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS, Substantially Equivalent on 1995-03-21. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code FBK
view allMore clearances from KARL STORZ Endoscopy-America, Inc.
view allAdverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K950976
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K950976.
Data sourced from openFDA. This site is unofficial and independent of the FDA.