Speculum, Vaginal, Metal, Fiberoptic
The Metal Fiberoptic Vaginal Speculum is a gynecological examination instrument combining a standard metal speculum with an integrated fiberoptic light source, providing enhanced illumination of the vaginal canal and cervix during pelvic examination and minor gynecological procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDG under regulation 21 CFR 884.4520 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HDG
- Device Class
- FDA class 1
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.