Product code HPS— Ophthalmic
BEAVER CATARACT CYROXTRACTOR
- Classification name
- Unit, Cryophthalmic
- Device class
- Class 2
- Regulation
- 21 CFR 886.4170
- Advisory panel
- Ophthalmic
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code HPS
FDA has cleared devices under product code HPS between 1979 and 2020, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 1994
- 1992
- 1990
- 1988
- 1987
- 1984
- 1980
- 1979
Top applicants under product code HPS
Recent clearances under product code HPS
- K202038 — CryoTreQ
- K940373 — OPHTHALMIC CRYO UNIT
- K923629 — OPHTHALMIC TRICHIASIS PROBE
- K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
- K874555 — KEELER ACU 22XT OPHTHALMIC CRYO UNIT
- K873388 — KEELER CTU CRYO SYSTEM
- K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS
- K833747 — GALLIE CRYONUCLEATOR
- K801418 — KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT
- K781338 — BEAVER CATARACT CYROXTRACTOR
- K790102 — MODEL 556-01 CRYOEXTRACTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.