Product code HDF— Obstetrics/Gynecology
61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA
- Classification name
- Speculum, Vaginal, Metal
- Device class
- Class 1
- Regulation
- 21 CFR 884.4520
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code HDF
FDA has cleared devices under product code HDF between 1982 and 1994, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1990
- 1989
- 1986
- 1985
- 1984
- 1982
Top applicants under product code HDF
Adverse events under product code HDF
product code HDF- Other
- 2
- Total
- 2
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 →
Recent clearances under product code HDF
- K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
- K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
- K891041 — MIYA SPECULUM
- K891044 — LASER SPECULA
- K890375 — VAGINAL SPECULUM
- K862478 — HAYES VAGINAL SHIELD
- K853640 — WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
- K851799 — 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA
- K843388 — WELLINGTON HOSPITAL PATTERN SELF-RETAIN
- K821291 — PEDERSON VAGINAL SPECULA
- K821297 — GRAVES SPECULA
Data sourced from openFDA. This site is unofficial and independent of the FDA.