Product code HMW
- Device name
- Drape, Microscope, 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 |
|---|---|---|---|
| K911040 | INVOTEC MICROSCOPE DRAPE | Invotec International, Inc. | 1991-06-03 |
| K902763 | STERILE INSTRUMENT DRAPE | North American Sterilization & Packaging Co. | 1990-09-20 |
| K902851 | MICROSCOPE DRAPE | Medical Technique Instruments, Inc. | 1990-09-10 |
| K843890 | CUSTOM INSTRUMENT DRAPE | Lifestream Int'L, Inc. | 1984-10-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10885403133893 | V. Mueller | CAREFUSION 2200, INC | 2017-10-17 |
| 10885403067532 | V. Mueller | CAREFUSION 2200, INC | 2017-10-17 |
| 00190769003555 | Vashe Sterile Sleeve | URGO MEDICAL NORTH AMERICA, LLC | 2017-07-17 |
| 00815384021158 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-24 |
| 00815384021127 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-24 |
| 00815384021097 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-24 |
| 00815384021066 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-24 |
| 00815384021035 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-24 |
| 00815384021004 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-24 |
| 00815384020878 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020335 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020397 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020427 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020458 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020519 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020540 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020984 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020953 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020922 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020892 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020571 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020847 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020816 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020786 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020755 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020724 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020694 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020663 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020632 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |
| 00815384020601 | OPTICS ONE | MEDICAL TECHNIQUE, INC. | 2016-09-23 |