HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241— 510(k) K000673

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

2000-02-28

Decision date

2000-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vernon Hills, IL, US

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• 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 →