KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE— 510(k) K951190
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K951190 for KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE, Substantially Equivalent on 1995-06-14. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code HET
- Device class
- Class 2
- Regulation
- 21 CFR 884.1720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code HET
view allMore clearances from KARL STORZ Endoscopy-America, Inc.
view allAdverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
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 K951190
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 K951190.
Data sourced from openFDA. This site is unofficial and independent of the FDA.