Karl Storz Endoscopy America Inc
Karl Storz Endoscopy America Inc appears in FDA public data with 17 recalls, 30 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0527-2014, Class II) was initiated on November 13, 2013. Its most recent 510(k) clearance was granted on October 22, 2024.
Summary
- Total Recalls
- 17
- 510(k) Clearances
- 30
- Inspections
- 5
- Compliance Actions
- 0
Known Names
karl storz endoscopy america, karl storz endoscopy_america
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0527-2014 | Class II | Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination an | November 13, 2013 |
| Z-0526-2014 | Class II | Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, | November 13, 2013 |
| Z-0465-2014 | Class II | Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey | November 6, 2013 |
| Z-1728-2013 | Class II | 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion cat | May 31, 2013 |
| Z-1216-2013 | Class II | KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tri | August 16, 2012 |
| Z-1313-2013 | Class II | Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold k | June 1, 2009 |
| Z-1306-2013 | Class II | Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops a | June 1, 2009 |
| Z-1312-2013 | Class II | Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and | June 1, 2009 |
| Z-1308-2013 | Class II | Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loop | June 1, 2009 |
| Z-1310-2013 | Class II | Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops a | June 1, 2009 |
| Z-1311-2013 | Class II | Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutti | June 1, 2009 |
| Z-1314-2013 | Class II | Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold | June 1, 2009 |
| Z-1309-2013 | Class II | Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops | June 1, 2009 |
| Z-1316-2013 | Class II | Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and | June 1, 2009 |
| Z-1315-2013 | Class II | Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting | June 1, 2009 |
| Z-1307-2013 | Class II | Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops | June 1, 2009 |
| Z-1305-2013 | Class II | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and c | June 1, 2009 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K240506 | KARL STORZ Holders | October 22, 2024 |
| K223885 | HOPKINS Telescopes | September 14, 2023 |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. | June 23, 2023 |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | March 17, 2023 |
| K221004 | HOPKINS Telescopes | December 20, 2022 |
| K222504 | H1 | November 10, 2022 |
| K213194 | HD Mediastinoscope | June 23, 2022 |
| K221174 | Telepack + | May 13, 2022 |
| K212458 | Flexible Video-Uretero-Renoscope SSU System | January 20, 2022 |
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) | December 29, 2021 |
| K212695 | KARL STORZ ICG Imaging System | November 15, 2021 |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | September 3, 2021 |
| K203198 | KARL STORZ Metal Sterilization Trays | July 6, 2021 |
| K202272 | HD Mediastinoscope | May 11, 2021 |
| K203572 | Karl Storz Radel Sterilization Trays | May 7, 2021 |
| K201001 | Modulith SLX-F2 | March 30, 2021 |
| K201945 | KARL STORZ UDEL Sterilization Trays | February 25, 2021 |
| K200965 | XR-MX/1000 | December 29, 2020 |
| K201526 | TIPCAM1 Rubina Video Endoscope System | November 20, 2020 |
| K201096 | CO2mbiLED | June 23, 2020 |