Speculum, Vaginal, Nonmetal, Fiberoptic
The Nonmetal Fiberoptic Vaginal Speculum is a plastic or non-metallic vaginal speculum incorporating fiberoptic light transmission to illuminate the cervix and vaginal walls during examination, eliminating the need for a separate external light source. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty, subject to premarket controls. The product code is HIC, regulated under 21 CFR 884.4530. No special risk flags apply.
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Basic Information
- Product Code
- HIC
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | Mar 21, 1996 | Substantially Equivalent | Trylon Corp. |
| K923656 | LIGHTING SOURCE SYSTEM | Sep 08, 1994 | Substantially Equivalent | Galenica Enterprises, Inc. |
| K902516 | NEW LENGTH SUGITA APPLIERS | Jul 03, 1990 | Substantially Equivalent | Sims Surgical, Inc. |
| K897100 | CENTURION VAGINAL SPECULUM | Mar 16, 1990 | Substantially Equivalent | Tri-State Hospital Supply Corp. |
| K853257 | SPECULITE DISPOSABLE VAGINAL LIGHT | Dec 27, 1985 | Substantially Equivalent | Trylon Associates, Ltd. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.