KSEA MONOPOLAR VAPORIZATION ELECTRODES— 510(k) K983569

Clearance details

Applicant

KARL STORZ Endoscopy-America, Inc.

Product code

Code HIH

Device class

Class 2

Regulation

21 CFR 884.1690

Advisory panel

Obstetrics/Gynecology

Date received

1998-10-13

Decision date

1999-01-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Culver City, CA, US

• K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)2026-09-08
• K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)2026-08-18
• K253020 — Strauss Surgical Resection Instruments2026-06-04
• K254050 — Manual Tissue Removal Device2026-05-15
• K254251 — InnovexView (GC146-17, GC150-20, GC155-23)2026-02-26

• 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

18

Injury

973

Malfunction

5,071

Other

1

Total

6,063

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 K983569.