KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION— 510(k) K934647

Clearance details

Applicant

KARL STORZ Endoscopy-America, Inc.

Product code

Code FJL

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

1993-09-29

Decision date

1994-02-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Culver City, CA, US

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• K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable2023-03-17
• K230205 — Veloxion System2023-02-24
• K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags2019-06-13
• K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch2019-03-15

• K252624 — KARL STORZ Laryngoscopes and Accessories2026-05-15
• K240506 — KARL STORZ Holders2024-10-22
• K223885 — HOPKINS Telescopes2023-09-14
• K230359 — KOH Ultramicro Injection Cannula (26167NN) +11 more2023-06-23
• K223520 — UNIDRIVE SIII System2023-04-27

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1305-2013 — Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1306-2013 — Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1307-2013 — Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1308-2013 — Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1309-2013 — Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1310-2013 — Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1311-2013 — Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1312-2013 — Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1313-2013 — Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1314-2013 — Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1315-2013 — Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601
• Z-1316-2013 — Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).Class II·Terminated·Karl Storz Endoscopy America Inc·20090601

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934647.