Product code HMT
- Device name
- Drape, Patient, Ophthalmic
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4370
- Review panel
- HO
- 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 |
|---|---|---|---|
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Visitec Co. | 1995-02-14 |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | Angiosystems, Inc. | 1991-02-06 |
| K872620 | SOLOS EYESITE DRAPES | Solos Ophthalmology | 1987-07-31 |
| K871706 | OPTHA PREP | Treace Medical, Inc. | 1987-05-18 |
| K854613 | SURGICAL DRAPES, OPHTHALMIN | Charles Atkins & Co. | 1986-02-13 |
| K831340 | DRAIN-R-DRAPE(EYE | Sur-Tech, Inc. | 1983-06-08 |
| K830822 | EYE DRAPE | CooperVision, Inc. | 1983-04-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253066685 | CONVERTORS | Cardinal Health 200, LLC | 2025-06-18 |
| 10192253066678 | CONVERTORS | Cardinal Health 200, LLC | 2025-06-18 |
| 10192253066661 | CONVERTORS | Cardinal Health 200, LLC | 2025-06-18 |
| 10192253066647 | CONVERTORS | Cardinal Health 200, LLC | 2025-06-18 |
| 10192253066630 | CONVERTORS | Cardinal Health 200, LLC | 2025-06-18 |
| 10192253020632 | CONVERTORS | Cardinal Health 200, LLC | 2019-08-07 |
| 10192253020625 | CONVERTORS | Cardinal Health 200, LLC | 2019-08-07 |
| 10810003220186 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220285 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220193 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220209 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220216 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220223 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220230 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220247 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220254 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220261 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220278 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220179 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10080196001903 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10809160057797 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-10 |
| 10809160069523 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-09 |
| 10885380071539 | CONVERTORS | Cardinal Health 200, LLC | 2016-07-13 |
| 00630140030775 | CONVERTORS | Cardinal Health 200, LLC | 2016-07-13 |
| 00630140027515 | CONVERTORS | Cardinal Health 200, LLC | 2016-07-13 |
| 10885380058134 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-29 |
| 10885380109454 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-22 |
| 10885380109447 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-22 |
| 50885380059092 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-21 |
| 50885380058019 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-21 |