Cleared Traditional

K961524 - STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS

K961524 is an FDA 510(k) clearance for STERILAB CANNULAS, manufactured by Sterilab, Inc.. The device is a Class 1 Ophthalmic device with product code HNY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K961524 · Sterilab, Inc. · Ophthalmic device
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May 1996
Decision
24d
Days
Class 1
Risk

K961524 is an FDA 510(k) clearance for the STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MAN.... Classified as Cystotome (product code HNY), Class I - General Controls.

Submitted by Sterilab, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 16, 1996 after a review of 24 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterilab, Inc. devices

FDA 510(k) Submission Details - K961524

510(k) Number K961524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date May 16, 1996
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
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 9
Devices cleared under the same product code (HNY) and FDA review panel - the closest regulatory comparables to K961524.
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
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K875001 · Advanced Surgical Products, Inc. · Apr 1988