Drape, Microscope, Ophthalmic
The Ophthalmic Microscope Drape is a sterile surgical barrier used to cover the operating microscope during ophthalmic procedures, preventing contamination of the sterile surgical field while maintaining optical accessibility through the microscope. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is HMW, regulated under 21 CFR 878.4370, within the General and Plastic Surgery medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HMW
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 03, 1991 | Substantially Equivalent | Invotec International, Inc. |
| K902763 | STERILE INSTRUMENT DRAPE | Sep 20, 1990 | Substantially Equivalent | North American Sterilization & Packaging Co. |
| K902851 | MICROSCOPE DRAPE | Sep 10, 1990 | Substantially Equivalent | Medical Technique Instruments, Inc. |
| K843890 | CUSTOM INSTRUMENT DRAPE | Oct 26, 1984 | Substantially Equivalent | Lifestream Int'L, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.