HNY · Class I · 21 CFR 886.4350

FDA Product Code HNY: Cystotome

Leading manufacturers include Advanced Surgical Products, Inc., Visitec Co. and CooperVision, Inc..

20
Total
20
Cleared
65d
Avg days
1979
Since

FDA 510(k) Cleared Cystotome Devices (Product Code HNY)

20 devices
1–20 of 20
Cleared May 16, 1996
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
K961524
Sterilab, Inc.
Ophthalmic · 24d
Cleared Apr 13, 1988
PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME
K874975
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
K874976
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
K874983
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
K874993
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
K874997
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K875001
Advanced Surgical Products, Inc.
Ophthalmic · 131d
Cleared Feb 20, 1987
LOOK IRRIGATING CYSTOTOMES
K870439
Look, Inc.
Ophthalmic · 17d
Cleared Jul 12, 1983
DISPOSABLE CYSTOTOME
K831916
CooperVision, Inc.
Ophthalmic · 28d
Cleared Feb 12, 1979
CYSTOTOMES
K790244
Visitec Co.
Ophthalmic · 45d

About Product Code HNY - Regulatory Context