STORS SCLERAL SPONGE II (LINCOFF DESIGN)
FDA 510(k) clearance K950599 · decided 1995-03-02
Clearance details
- K-number
- K950599
- Device name
- STORS SCLERAL SPONGE II (LINCOFF DESIGN)
- Applicant
- Storz Ophthalmics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-09
- Decision date
- 1995-03-02
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HQX
- Device class
- 2
- Regulation number
- 886.3340
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Clearwater, FL, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS (P800017/S004) | Storz Ophthalmics, Inc. | 1988-01-27 |
| CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS (P800017/S003) | Storz Ophthalmics, Inc. | 1987-09-21 |
| CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS (P800017/S002) | Storz Ophthalmics, Inc. | 1985-08-08 |
| BINKHORST & FEDOROV I IRIS CLIP IOLS (P800027) | Storz Ophthalmics, Inc. | 1982-07-26 |
| CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS (P800017) | Storz Ophthalmics, Inc. | 1981-12-01 |