WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES— 510(k) K980302

Clearance details

Applicant

Richard Wolf Medical Instruments Corp.

Product code

Code HIH

Device class

Class 2

Regulation

21 CFR 884.1690

Advisory panel

Obstetrics/Gynecology

Date received

1998-01-27

Decision date

1998-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vernon Hills, IL, 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

• K151282 — core nova Complete Operating Room Endoscopy2016-01-12
• K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 55252013-04-03
• K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.22012-09-20
• K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA2012-08-03
• K090776 — MEGAPULSE LASER SYSTEM AND FIBERS2009-06-02

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-1957-2019 — E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.Class II·Terminated·Richard Wolf Medical Instruments Corp.·20190523

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980302.