United Surgical Corp. Cryoptic Plus
FDA 510(k) K870195 · United Surgical Corp.
510(k) numberK870195
Submission
- Device name
- United Surgical Corp. Cryoptic Plus
- Applicant
- United Surgical Corp.
Irvine, CA, US - Received
- January 20, 1987
- Decision date
- February 20, 1987
- 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 |
| K903303 | Spembly Medical 242 Cryounit/Series 242 CryoprobesHPS · Traditional | Spembly Medical , Ltd. | 10/11/1990SE |
| 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 |
| 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 |
|---|---|---|
| K902150 | Piezo HandpieceHQC · Traditional | 07/05/1990SE |
| K870671 | Phacotron Day PakHQC · Traditional | 04/06/1987SE |
| K870806 | Non-Sterile, Extra Plus Pak Cat. #Uspk 2100HQC · Traditional | 03/26/1987SE |
| K870194 | United Surgical Corp. Diathermic PlusHQR · Traditional | 02/20/1987SE |
| K860014 | Systems PlusHQE · Traditional | 03/05/1986SE |
| K830741 | Parametric Sterility Release of AutoGAG · Traditional | 08/11/1983SE |
Questions and answers
When was United Surgical Corp. Cryoptic Plus cleared by the FDA?
United Surgical Corp. Cryoptic Plus (K870195) received a 510(k) decision of Substantially Equivalent on February 20, 1987, 31 days after the submission was received.
What is the product code of K870195?
The FDA product code is HPS – Unit, Cryophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4170.