HKP · Class II · 21 CFR 886.4150

FDA Product Code HKP: Instrument, Vitreous Aspiration And Cutting, Battery-powered

Leading manufacturers include Varian Assoc., Inc., Concept, Inc. and Mentor O & O, Inc..

16
Total
16
Cleared
107d
Avg days
1976
Since

FDA 510(k) Cleared Instrument, Vitreous Aspiration And Cutting, Battery-powered Devices (Product Code HKP)

16 devices
1–16 of 16
Cleared Mar 19, 1997
AARON VAC 2
K952558
Aaron Medical Industries
Ophthalmic · 656d
Cleared Apr 10, 1995
UNIVIT PROBE
K950287
Medical Instrument Development Laboratories, Inc.
Ophthalmic · 76d
Cleared Apr 04, 1990
VISITEC VITRECTOMY UNIT
K896622
Visitec Co.
Ophthalmic · 134d
Cleared Apr 17, 1989
MENTOR ANTERIOR SEGMENT VITRECTOR
K890595
Mentor O & O, Inc.
Ophthalmic · 70d
Cleared Aug 01, 1983
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K832074
CooperVision, Inc.
Ophthalmic · 34d
Cleared Dec 31, 1981
EMERGENCY POWER PAC (EMPAC)
K813273
Optical Micro Systems, Inc.
Ophthalmic · 41d
Cleared Sep 04, 1979
VITREOUS SUCTION/CUTTER
K791000
Concept, Inc.
Ophthalmic · 98d
Cleared Aug 28, 1979
STAT
K790893
Varian Assoc., Inc.
Ophthalmic · 112d
Cleared Nov 03, 1978
CLINITEX VIS-X ASPIRATING ACCESSORY
K780852
Varian Assoc., Inc.
Ophthalmic · 165d
Cleared Jan 05, 1977
VITEROUS SUCTION CUTTER
K761353
Concept, Inc.
Ophthalmic · 8d
Cleared Oct 05, 1976
VISC X-VITREOUS ASPIRATING & CUT. INSTR
K760684
Varian Assoc., Inc.
Ophthalmic · 15d

About Product Code HKP - Regulatory Context