EndoSerter-PL
FDA 510(k) clearance K203586 · decided 2022-02-02
Clearance details
- K-number
- K203586
- Device name
- EndoSerter-PL
- Applicant
- Corneagen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-12-08
- Decision date
- 2022-02-02
- Days to decision
- 421 days
- Clearance type
- Traditional
- Product code
- OTZ
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Winston-Salem, NC, 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 |
|---|---|---|
| EK DELIVERY DEVICE (K121579) | Tdak Medical, Inc. | 2012-10-03 |
| NCI SPATULA (K110734) | Fischer Surgical, Inc. | 2012-05-31 |
| TRIMOTION INJECTOR (K102999) | Kaneka Corp. | 2011-12-29 |
| ENDOSERTER (K090626) | Ocular Systems, Inc. | 2011-01-21 |
Recalls involving this device
No recalls on record reference this clearance.