ELLIPTI-PUNCH
FDA 510(k) clearance K854159 · decided 1985-11-15
Clearance details
- K-number
- K854159
- Device name
- ELLIPTI-PUNCH
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-10-11
- Decision date
- 1985-11-15
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FZI
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fort Worth, TX, 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 |
|---|---|---|
| MULTIPLE, SURGICAL DRAPE PACK (K911132) | Central Georgia Ancillary Health Systems | 1991-05-06 |
| STERILE DISPOSABLE DRAPE(S) (K910468) | E.M. Adams | 1991-03-21 |
| DAVIS RHYTIDECTOMY (K772395) | Edward Weck, Inc. | 1978-03-09 |
| KALRN FACE-LIFE SCISSORS (K772394) | Edward Weck, Inc. | 1978-03-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (P840064/S091) | Alcon Laboratories | 2025-10-03 |
| VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Ophthalmic Viscosurgical Device (P840064/S090) | Alcon Laboratories | 2025-07-25 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088) | Alcon Laboratories | 2025-02-26 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086) | Alcon Laboratories | 2024-08-12 |
| PMMA Single-Piece Anterior Chamber IOL (P880087/S033) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071) | Alcon Laboratories | 2024-06-20 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S085) | Alcon Laboratories | 2024-06-17 |