KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC— 510(k) K934937
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K934937 for KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC, Substantially Equivalent on 1994-03-23. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Product code GCJ
- 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 GCJ
view allMore clearances from KARL STORZ Endoscopy-America, Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 K934937
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 K934937.
Data sourced from openFDA. This site is unofficial and independent of the FDA.