Spembly Medical 242 Cryounit/Series 242 Cryoprobes
FDA 510(k) K903303 · Spembly Medical , Ltd.
510(k) numberK903303
Submission
- Device name
- Spembly Medical 242 Cryounit/Series 242 Cryoprobes
- Applicant
- Spembly Medical , Ltd.
England, GB - Received
- July 24, 1990
- Decision date
- October 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPS – Unit, Cryophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Specialty
- Ophthalmic
Other 510(k)s with product code HPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202038 | CryoTreQHPS · Traditional | VitreQ BV | 12/30/2020SE |
| K940373 | Ophthalmic Cryo UnitHPS · Traditional | Dutch Ophthalmic USA, Inc. | 07/18/1994SE |
| K923629 | Ophthalmic Trichiasis ProbeHPS · Traditional | Mira, Inc. | 10/19/1992SE |
| K874555 | Keeler Acu 22XT Ophthalmic Cryo UnitHPS · Traditional | Keeler Instruments, Inc. | 01/29/1988SE |
| K873388 | Keeler Ctu Cryo SystemHPS · Traditional | Keeler Instruments, Inc. | 11/13/1987SE |
| K870195 | United Surgical Corp. Cryoptic PlusHPS · Traditional | United Surgical Corp. | 02/20/1987SE |
| K833747 | Gallie CryonucleatorHPS · Traditional | Mono Research Laboratories | 05/09/1984SE |
| K801418 | Keeler Amoils Acull Cryo Ophthalmic UnitHPS · Traditional | Keeler Optical Products , Ltd. | 07/21/1980SE |
| K790102 | Model 556-01 CryoextractorHPS · Traditional | Intermedics, Inc. | 02/12/1979SE |
| K781338 | Beaver Cataract CyroxtractorHPS · Traditional | Edward Weck, Inc. | 02/12/1979SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925129 | SelectorGCJ · Traditional | 04/23/1993SE |
| K901974 | Selector Ultrasonic Surgical AspiratorLFL · Traditional | 09/05/1990SE |
| K882568 | 130 Cryo Unit & Assoc. Cryoprobes & SprayGEH · Traditional | 09/27/1988SE |
| K882963 | Spembly Medical 142 Cryo UnitGEH · Traditional | 08/08/1988SE |
| K882962 | Series 40 & Series 42 Cryoprobes (R Series)GEH · Traditional | 08/08/1988SE |
| K874367 | Various Cardiac Cryoprobes Having Dia. & Cos. DiffHQO · Traditional | 01/04/1988SE |
| K840497 | Obstetric Pulsar Two Channel TENSGZJ · Traditional | 04/16/1984SE |
| K832385 | Cryoprobes MC-1400-CRYOSURG-CONSOLEGEH · Traditional | 09/12/1983SE |
| K832334 | Cryomedics 5000 Cryosurgical ConsoleGEH · Traditional | 08/12/1983SE |
| K832140 | Cryomedics 5000 CryoprobesGEH · Traditional | 08/12/1983SE |
Questions and answers
When was Spembly Medical 242 Cryounit/Series 242 Cryoprobes cleared by the FDA?
Spembly Medical 242 Cryounit/Series 242 Cryoprobes (K903303) received a 510(k) decision of Substantially Equivalent on October 11, 1990, 79 days after the submission was received.
What is the product code of K903303?
The FDA product code is HPS – Unit, Cryophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4170.