Sterile/Disposable HSG Tray
FDA 510(k) K810291 · Unimar, Inc.
510(k) numberK810291
Submission
- Device name
- Sterile/Disposable HSG Tray
- Applicant
- Unimar, Inc.
Mchenry, IL, US - Received
- February 3, 1981
- Decision date
- March 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYY – Drape, Urological, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code EYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851675 | The Percutaneous Nephrostolithotomy DrapeEYY · Traditional | Lingeman Medical Products, Inc. | 05/14/1985SE |
More from Lingeman Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K932432 | Kronner Reinforcing StyletteLKF · Traditional | 04/12/1994SE |
| K920803 | HSG TrayHIB · Traditional | 10/19/1992SEKD |
| K910317 | Uni-Sem(Tm)MFD · Traditional | 05/01/1991SE |
| K904473 | Kronner ManipujectorHES · Traditional | 12/14/1990SE |
| K895659 | Hui Mini-FlexHIG · Traditional | 12/19/1989SE |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | 11/29/1989SE |
| K894264 | KDF-2.3HDR · Traditional | 08/15/1989SE |
| K890848 | Cervex-BrushHHT · Traditional | 05/11/1989SE |
| K854415 | Endometrial PipelleHHK · Traditional | 03/13/1986SE |
Questions and answers
When was Sterile/Disposable HSG Tray cleared by the FDA?
Sterile/Disposable HSG Tray (K810291) received a 510(k) decision of Substantially Equivalent on March 18, 1981, 43 days after the submission was received.
What is the product code of K810291?
The FDA product code is EYY – Drape, Urological, Disposable, a Class II (moderate risk) device regulated under 21 CFR 878.4370.