SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
FDA 510(k) clearance K903303 · decided 1990-10-11
Clearance details
- K-number
- K903303
- Device name
- SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
- Applicant
- Spembly Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-24
- Decision date
- 1990-10-11
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HPS
- Device class
- 2
- Regulation number
- 886.4170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- England, GB
- 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 |
|---|---|---|
| CryoTreQ (K202038) | VitreQ BV | 2020-12-30 |
| OPHTHALMIC CRYO UNIT (K940373) | Dutch Ophthalmic USA, Inc. | 1994-07-18 |
| OPHTHALMIC TRICHIASIS PROBE (K923629) | Mira, Inc. | 1992-10-19 |
| KEELER ACU 22XT OPHTHALMIC CRYO UNIT (K874555) | Keeler Instruments, Inc. | 1988-01-29 |
| KEELER CTU CRYO SYSTEM (K873388) | Keeler Instruments, Inc. | 1987-11-13 |
| UNITED SURGICAL CORP. CRYOPTIC PLUS (K870195) | United Surgical Corp. | 1987-02-20 |
| GALLIE CRYONUCLEATOR (K833747) | Mono Research Laboratories | 1984-05-09 |
| KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT (K801418) | Keeler Optical Products , Ltd. | 1980-07-21 |
| BEAVER CATARACT CYROXTRACTOR (K781338) | Edward Weck, Inc. | 1979-02-12 |
| MODEL 556-01 CRYOEXTRACTOR (K790102) | Intermedics, Inc. | 1979-02-12 |
Recalls involving this device
No recalls on record reference this clearance.