Clamp, Muscle, Ophthalmic
An Ophthalmic Muscle Clamp is a surgical instrument used to grasp and temporarily occlude or hold extraocular muscles during strabismus surgery or other procedures requiring manipulation of the muscles that control eye movement. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification or approval. It carries product code HOB and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
Basic Information
- Product Code
- HOB
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K840310 | CATEGORY 6 OPTHALMIC DEVICES | Mar 16, 1984 | Substantially Equivalent | IMM ENTERPRISES LTD. |
| K840101 | EYE SURGERY INSTRUMENT | Mar 16, 1984 | Substantially Equivalent | TRULINE INSTRUMENTS, INC. |
| K780851 | CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC | Jun 30, 1978 | Substantially Equivalent | VARIAN ASSOC., INC. |
FEI Numbers
This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.