Product Code: HNY FDA class 1 21 CFR 886.4350

Cystotome

Ophthalmic

A Cystotome is a fine ophthalmic surgical instrument with a small hook or needle tip used to create an opening in the anterior lens capsule during cataract surgery, enabling removal of the lens nucleus and cortex while preserving the capsular bag for lens implant placement. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket submission. It carries product code HNY and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: HNY
Device Class: FDA class 1
Regulation Number: 886.4350
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K961524	STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS	May 16, 1996	Substantially Equivalent	Sterilab, Inc.
K880345	CYSTOTOMES/KNIFES	May 03, 1988	Substantially Equivalent	Myocure, Inc.
K875001	PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874997	PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874993	PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874983	PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874976	PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874975	PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K873163	VAN DELLEN IRRIGATING CYSTOTOME	Sep 04, 1987	Substantially Equivalent	Van Dellen, Ltd.
K871365	CAPSULECTOMER CYSTOTOME	Apr 16, 1987	Substantially Equivalent	Noetix, Inc.
K870439	LOOK IRRIGATING CYSTOTOMES	Feb 20, 1987	Substantially Equivalent	Look, Inc.
K862709	MECHANICAL CYSTITOME	Aug 01, 1986	Substantially Equivalent	Rudolph Beaver, Inc.
K852934	PRECISION - COSMET CAPSULE COUPEUR	Aug 08, 1985	Substantially Equivalent	Precision-Cosmet Co., Inc.
K841101	CLAYMAN-PAREL CAPSULE COUPEUR	May 16, 1984	Substantially Equivalent	Miami Eye Technology, Inc.
K840475	CYSTOTOME, 140-S	Apr 05, 1984	Substantially Equivalent	Cilco, Inc.
K840660	POSTERIOR CAPSULOTOMY CYSTITOME	Mar 16, 1984	Substantially Equivalent	Sharpoint, Inc.
K840659	ANTERIOR CAPSULECTOMY CYSTITOME	Mar 16, 1984	Substantially Equivalent	Sharpoint, Inc.
K831916	DISPOSABLE CYSTOTOME	Jul 12, 1983	Substantially Equivalent	CooperVision, Inc.
K830040	DISPOSABLE CYSTOTOME	Feb 07, 1983	Substantially Equivalent	Contemporary Surgical Systems, Inc.
K790244	CYSTOTOMES	Feb 12, 1979	Substantially Equivalent	Visitec Co.