Karl Storz Endoscopy America Inc

FDA Regulatory Profile

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

NumberClassProductDate
Z-0526-2014Class IIIntubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, November 13, 2013
Z-0527-2014Class IIBroncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination anNovember 13, 2013
Z-0465-2014Class IIAxillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD DebakeyNovember 6, 2013
Z-1728-2013Class II27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catMay 31, 2013
Z-1216-2013Class IIKARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, TriAugust 16, 2012
Z-1313-2013Class IILoop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold kJune 1, 2009
Z-1306-2013Class IIElectrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops aJune 1, 2009
Z-1312-2013Class IIElectrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops andJune 1, 2009
Z-1311-2013Class IIElectrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cuttiJune 1, 2009
Z-1307-2013Class IIElectrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loopsJune 1, 2009
Z-1305-2013Class IIElectrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cJune 1, 2009
Z-1315-2013Class IIElectrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cuttingJune 1, 2009
Z-1310-2013Class IIElectrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops aJune 1, 2009
Z-1309-2013Class IIElectrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops June 1, 2009
Z-1316-2013Class IILoop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops andJune 1, 2009
Z-1308-2013Class IIElectrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loopJune 1, 2009
Z-1314-2013Class IIKnife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and coldJune 1, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K240506KARL STORZ HoldersOctober 22, 2024
K223885HOPKINS TelescopesSeptember 14, 2023
K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. June 23, 2023
K221893KARL STORZ Bipolar Resectoscopes with HF CableMarch 17, 2023
K221004HOPKINS TelescopesDecember 20, 2022
K222504H1November 10, 2022
K213194HD MediastinoscopeJune 23, 2022
K221174Telepack +May 13, 2022
K212458Flexible Video-Uretero-Renoscope SSU SystemJanuary 20, 2022
K212656Flexible Intubation Video Endoscope – Sterile (FIVE-S)December 29, 2021
K212695KARL STORZ ICG Imaging SystemNovember 15, 2021
K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemSeptember 3, 2021
K203198KARL STORZ Metal Sterilization TraysJuly 6, 2021
K202272HD MediastinoscopeMay 11, 2021
K203572Karl Storz Radel Sterilization TraysMay 7, 2021
K201001Modulith SLX-F2March 30, 2021
K201945KARL STORZ UDEL Sterilization TraysFebruary 25, 2021
K200965XR-MX/1000December 29, 2020
K201526TIPCAM1 Rubina Video Endoscope SystemNovember 20, 2020
K201096CO2mbiLEDJune 23, 2020