Cleared Traditional

K874975 - PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME

K874975 is an FDA 510(k) clearance for PRISMA DISPOSABLE SHARP ANGLED IRRIGAT...., manufactured by Advanced Surgical Products, Inc.. The device is a Class 1 Ophthalmic device with product code HNY cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K874975 · Advanced Surgical Products, Inc. · Ophthalmic device
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Apr 1988
Decision
133d
Days
Class 1
Risk

K874975 is an FDA 510(k) clearance for the PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME. Classified as Cystotome (product code HNY), 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 - K874975

510(k) Number K874975 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.

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 K874975.
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
K961524 · Sterilab, Inc. · May 1996
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