FDA Product Code
FDA Product Code HDF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4520
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Thomasville Medical Assoc. | 1994-02-28 | Traditional | PDF ↗ |
| K902019 | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | Gynescope Corp. | 1990-06-07 | Traditional | PDF ↗ |
| K891041 | MIYA SPECULUM | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K891044 | LASER SPECULA | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K890375 | VAGINAL SPECULUM | Kinetic Medical Products | 1989-02-13 | Traditional | PDF ↗ |
| K862478 | HAYES VAGINAL SHIELD | Franklin Medical USA, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | Downs Surgical , Ltd. | 1985-10-29 | Traditional | PDF ↗ |
| K851799 | 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA | Artiberia | 1985-05-22 | Traditional | PDF ↗ |
| K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | Downs Surgical , Ltd. | 1984-10-01 | Traditional | PDF ↗ |
| K821291 | PEDERSON VAGINAL SPECULA | Conphar, Inc. | 1982-05-24 | Traditional | PDF ↗ |
| K821297 | GRAVES SPECULA | Conphar, Inc. | 1982-05-24 | Traditional | PDF ↗ |
Product code HDF · Class I · Obstetrics/Gynecology. Data: openFDA.