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 |
|---|---|---|---|
| 00198506091827 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-10 |
| 00198506091834 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-10 |
| 00198506091803 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-10 |
| 00850083275365 | Intrace USA | PILOTIS TECH LLC | 2026-07-03 |
| 00190776421632 | Millennium | Avalign Technologies, Inc. | 2026-06-23 |
| 00810158211360 | PRINCETON | Princeton Medical Group, Inc. | 2026-06-23 |
| 05060411982314 | Cusco Specula Metal Large Long | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411985117 | Cusco Specula Metal Small XXLong | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411984462 | Cusco Specula Metal Medium Long | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411982369 | Cusco Specula Metal Broad | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411982321 | Cusco Specula Metal Large Extra Long | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212052360 | Cusco Specula Metal Large | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212052346 | Cusco Specula Metal Medium | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060212052339 | Cusco Specula Metal Small | DTR MEDICAL LIMITED | 2026-06-10 |
| 00198506091490 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| G586OB631721NCDT0 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586OB633804NC0 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586OB631723NCDT0 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
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| 10381780201953 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |
| 10381780201960 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |
| 10381780201977 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |
| 10381780201984 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |
| 10381780201991 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |