Product code HDF
- Device name
- Speculum, Vaginal, Metal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.4520
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Thomasville Medical Assoc. | 1994-02-28 |
| K902019 | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | Gynescope Corp. | 1990-06-07 |
| K891041 | MIYA SPECULUM | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| K891044 | LASER SPECULA | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K890375 | VAGINAL SPECULUM | Kinetic Medical Products | 1989-02-13 |
| K862478 | HAYES VAGINAL SHIELD | Franklin Medical USA, Inc. | 1986-11-24 |
| K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | Downs Surgical , Ltd. | 1985-10-29 |
| K851799 | 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA | Artiberia | 1985-05-22 |
| K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | Downs Surgical , Ltd. | 1984-10-01 |
| K821291 | PEDERSON VAGINAL SPECULA | Conphar, Inc. | 1982-05-24 |
| K821297 | GRAVES SPECULA | Conphar, Inc. | 1982-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G586OB631723NCDT0 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586OB633804NC0 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586OB631721NCDT0 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
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