MONOPOLAR INJECTION NEEDLE ELECTRODE
FDA 510(k) clearance K854793 · decided 1986-02-18
Clearance details
- K-number
- K854793
- Device name
- MONOPOLAR INJECTION NEEDLE ELECTRODE
- Applicant
- Oculinum, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1985-12-05
- Decision date
- 1986-02-18
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HLW
- Device class
- 2
- Regulation number
- 886.1640
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mill Valley, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MONOPOLAR NEEDLE ELECTRODE (K900098) | Oculinum, Inc. | 1990-02-09 |
| OCULINUM INJECTION AMPLIFIER (K900279) | Oculinum, Inc. | 1990-02-09 |
Recalls involving this device
No recalls on record reference this clearance.