Speculum, Vaginal, Metal
The Metal Vaginal Speculum is a reusable gynecological instrument with two hinged blades used to gently dilate and hold open the vaginal walls, providing visualization of the vaginal canal and cervix during examination and minor procedures such as Pap smear collection or cervical biopsy. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDF under regulation 21 CFR 884.4520 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
Research product code HDF in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HDF
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Feb 28, 1994 | Substantially Equivalent | Thomasville Medical Assoc. |
| K902019 | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | Jun 07, 1990 | Substantially Equivalent | Gynescope Corp. |
| K891041 | MIYA SPECULUM | Mar 22, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K891044 | LASER SPECULA | Mar 17, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K890375 | VAGINAL SPECULUM | Feb 13, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K862478 | HAYES VAGINAL SHIELD | Nov 24, 1986 | Substantially Equivalent | Franklin Medical USA, Inc. |
| K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | Oct 29, 1985 | Substantially Equivalent | Downs Surgical , Ltd. |
| K851799 | 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA | May 22, 1985 | Substantially Equivalent | Artiberia |
| K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | Oct 01, 1984 | Substantially Equivalent | Downs Surgical , Ltd. |
| K821297 | GRAVES SPECULA | May 24, 1982 | Substantially Equivalent | Conphar, Inc. |
| K821291 | PEDERSON VAGINAL SPECULA | May 24, 1982 | Substantially Equivalent | Conphar, Inc. |
FEI Numbers
This FDA classification entry is associated with 222 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 222 registration numbers. Click on an entry to view related FDA registrations.