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 |
|---|---|---|---|
| 00190776428242 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776428198 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776428181 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776428150 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776419622 | Millennium | Avalign Technologies, Inc. | 2026-08-23 |
| B382SD915039150 | Surgical Direct | Surgical Direct, Inc. | 2026-08-21 |
| B382SD915039140 | Surgical Direct | Surgical Direct, Inc. | 2026-08-21 |
| B382SD915039080 | Surgical Direct | Surgical Direct, Inc. | 2026-08-21 |
| 00198506094088 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-08-18 |
| 00198506093944 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-08-18 |
| 00190776426446 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| 00190776426439 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
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