HNY · Class I · 21 CFR 886.4350

FDA Product Code HNY: Cystotome

Leading manufacturers include Advanced Surgical Products, Inc., Sharpoint, Inc. and Look, 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 May 03, 1988
CYSTOTOMES/KNIFES
K880345
Myocure, Inc.
Ophthalmic · 98d
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 Sep 04, 1987
VAN DELLEN IRRIGATING CYSTOTOME
K873163
Van Dellen, Ltd.
Ophthalmic · 24d
Cleared Apr 16, 1987
CAPSULECTOMER CYSTOTOME
K871365
Noetix, Inc.
Ophthalmic · 9d
Cleared Feb 20, 1987
LOOK IRRIGATING CYSTOTOMES
K870439
Look, Inc.
Ophthalmic · 17d
Cleared Aug 01, 1986
MECHANICAL CYSTITOME
K862709
Rudolph Beaver, Inc.
Ophthalmic · 16d
Cleared Aug 08, 1985
PRECISION - COSMET CAPSULE COUPEUR
K852934
Precision-Cosmet Co., Inc.
Ophthalmic · 30d
Cleared May 16, 1984
CLAYMAN-PAREL CAPSULE COUPEUR
K841101
Miami Eye Technology, Inc.
Ophthalmic · 64d
Cleared Apr 05, 1984
CYSTOTOME, 140-S
K840475
Cilco, Inc.
Ophthalmic · 62d
Cleared Mar 16, 1984
ANTERIOR CAPSULECTOMY CYSTITOME
K840659
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Mar 16, 1984
POSTERIOR CAPSULOTOMY CYSTITOME
K840660
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Jul 12, 1983
DISPOSABLE CYSTOTOME
K831916
CooperVision, Inc.
Ophthalmic · 28d
Cleared Feb 07, 1983
DISPOSABLE CYSTOTOME
K830040
Contemporary Surgical Systems, Inc.
Ophthalmic · 31d
Cleared Feb 12, 1979
CYSTOTOMES
K790244
Visitec Co.
Ophthalmic · 45d

About Product Code HNY - Regulatory Context