Atlas FDA

HNY

20 FDA 510(k) clearances · Product code

45 daysmedian time to decision
133 days90th percentile
20clearances measured

FDA profile

Official device name
Cystotome
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Medical specialty
Ophthalmic
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RecordFirmDate
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS (K961524)Sterilab, Inc.1996-05-16
CYSTOTOMES/KNIFES (K880345)Myocure, Inc.1988-05-03
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (K874976)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (K874993)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (K875001)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (K874983)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (K874997)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (K874975)Advanced Surgical Products, Inc.1988-04-13
VAN DELLEN IRRIGATING CYSTOTOME (K873163)Van Dellen, Ltd.1987-09-04
CAPSULECTOMER CYSTOTOME (K871365)Noetix, Inc.1987-04-16
LOOK IRRIGATING CYSTOTOMES (K870439)Look, Inc.1987-02-20
MECHANICAL CYSTITOME (K862709)Rudolph Beaver, Inc.1986-08-01
PRECISION - COSMET CAPSULE COUPEUR (K852934)Precision-Cosmet Co., Inc.1985-08-08
CLAYMAN-PAREL CAPSULE COUPEUR (K841101)Miami Eye Technology, Inc.1984-05-16
CYSTOTOME, 140-S (K840475)Cilco, Inc.1984-04-05
POSTERIOR CAPSULOTOMY CYSTITOME (K840660)Sharpoint, Inc.1984-03-16
ANTERIOR CAPSULECTOMY CYSTITOME (K840659)Sharpoint, Inc.1984-03-16
DISPOSABLE CYSTOTOME (K831916)CooperVision, Inc.1983-07-12
DISPOSABLE CYSTOTOME (K830040)Contemporary Surgical Systems, Inc.1983-02-07
CYSTOTOMES (K790244)Visitec Co.1979-02-12

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Every clearance here is in the API, with alerts when new ones post.