KSEA NEURO-FIBERSCOPE— 510(k) K002788
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K002788 for KSEA NEURO-FIBERSCOPE, Substantially Equivalent on 2000-10-23. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code GWG
view allMore clearances from KARL STORZ Endoscopy-America, Inc.
view allAdverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
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 K002788
K-number listed on FDA's recall record- Z-1530-2020 — Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
- Z-1531-2020 — Karl Storz, Model # 11161C2, Flexible Neuroscope
- Z-1532-2020 — Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
- Z-2425-2019 — FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002788.
Data sourced from openFDA. This site is unofficial and independent of the FDA.