Cleared Traditional

K874969 - PRISMA DISPOSABLE KRATZ CAPSULE POLISHER

K874969 is an FDA 510(k) clearance for PRISMA DISPOSABLE KRATZ CAPSULE POLISHER, manufactured by Advanced Surgical Products, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K874969 · Advanced Surgical Products, Inc. · Ophthalmic device
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Apr 1988
Decision
133d
Days
Class 1
Risk

K874969 is an FDA 510(k) clearance for the PRISMA DISPOSABLE KRATZ CAPSULE POLISHER. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 133 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 Advanced Surgical Products, Inc. devices

FDA 510(k) Submission Details - K874969

510(k) Number K874969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1987
Decision Date April 13, 1988
Days to Decision 133 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 110d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
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 - HMX Cannula, Ophthalmic

All 48
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K874969.
VITREORETINAL INFUSION CANNULA
K904074 · Visitec Co. · Feb 1991
STORZ INFUSION CANNULA
K882884 · Storz Instrument Co. · Aug 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
K874968 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
K874970 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS
K874971 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA
K874972 · Advanced Surgical Products, Inc. · Apr 1988