Product code HIC
- Device name
- Speculum, Vaginal, Nonmetal, Fiberoptic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- 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 |
|---|---|---|---|
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | Trylon Corp. | 1996-03-21 |
| K923656 | LIGHTING SOURCE SYSTEM | Galenica Enterprises, Inc. | 1994-09-08 |
| K902516 | NEW LENGTH SUGITA APPLIERS | Sims Surgical, Inc. | 1990-07-03 |
| K897100 | CENTURION VAGINAL SPECULUM | Tri-State Hospital Supply Corp. | 1990-03-16 |
| K853257 | SPECULITE DISPOSABLE VAGINAL LIGHT | Trylon Associates, Ltd. | 1985-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10816908010846 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2021-11-15 |
| 10816908010839 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2021-11-15 |
| 10816908010822 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2021-11-15 |
| 00816908010849 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2021-11-15 |
| 00816908010832 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2021-11-15 |
| 00816908010825 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2021-11-15 |
| 10630094298051 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 00630094298016 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 10630094298020 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 10630094298013 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 00630094298023 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 00630094298054 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 00630094298078 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 00630094689012 | Bioseal Inc. | BIOSEAL | 2020-01-28 |
| 00816908010818 | Gynex SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2019-10-16 |
| 10816908010815 | Gynex SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2019-10-16 |
| 00816908010801 | Gynex SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2019-10-16 |
| 10816908010792 | Gynex SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2019-10-16 |
| 00816908010795 | Gynex SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2019-10-16 |
| 20816908010737 | SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2018-10-23 |
| 00816908010740 | SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2018-10-23 |
| 20816908010751 | SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2018-10-23 |
| 00816908010733 | SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2018-10-23 |
| 00816908010757 | SpecuLume EZ | CYALUME TECHNOLOGIES, INC. | 2018-10-23 |
| 20816908010621 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2017-04-05 |
| 20816908010638 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2017-04-05 |
| 20816908010645 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2017-04-05 |
| 00816908010627 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2017-04-05 |
| 00816908010634 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2017-04-05 |
| 00816908010641 | SpecuLume | CYALUME TECHNOLOGIES, INC. | 2017-04-05 |