MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL— 510(k) K122563
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K122563 for MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL, Substantially Equivalent on 2012-09-19. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, Inc.
- 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
- Special
- Location
- Malborough, MA, 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 Hologic, Inc.
view allAdverse 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.