Cleared Traditional

K880345 - CYSTOTOMES/KNIFES

K880345 is an FDA 510(k) clearance for CYSTOTOMES/KNIFES, manufactured by Myocure, Inc.. The device is a Class 1 Ophthalmic device with product code HNY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K880345 · Myocure, Inc. · Ophthalmic device
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May 1988
Decision
98d
Days
Class 1
Risk

K880345 is an FDA 510(k) clearance for the CYSTOTOMES/KNIFES. Classified as Cystotome (product code HNY), Class I - General Controls.

Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on May 3, 1988 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Myocure, Inc. devices

FDA 510(k) Submission Details - K880345

510(k) Number K880345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date May 03, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

HNY Device Classification - Class 1, General Controls

Product Code HNY Cystotome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNY Cystotome

All 10
Devices cleared under the same product code (HNY) and FDA review panel - the closest regulatory comparables to K880345.
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
K961524 · Sterilab, Inc. · May 1996
PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME
K874975 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
K874976 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
K874983 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
K874993 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
K874997 · Advanced Surgical Products, Inc. · Apr 1988