UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753— 510(k) K033113
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K033113 for UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753, Substantially Equivalent on 2003-12-23. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Recent devices under product code HIH
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- K253020 — Strauss Surgical Resection Instruments
- K254050 — Manual Tissue Removal Device
- K254251 — InnovexView (GC146-17, GC150-20, GC155-23)
More clearances from Richard Wolf Medical Instruments Corp.
view all- K151282 — core nova Complete Operating Room Endoscopy
- K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
- K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
- K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
- K090776 — MEGAPULSE LASER SYSTEM AND FIBERS
Adverse events under product code HIH
product code HIH- Death
- 18
- Injury
- 973
- Malfunction
- 5,071
- Other
- 1
- Total
- 6,063
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.