Cleared Traditional

K874993 - PRISMA DISPOSABLE SHARP IRRIGATING CYST...

K874993 is the FDA 510(k) clearance for PRISMA DISPOSABLE SHARP IRRIGATING CYST... by Advanced Surgical Products, Inc.. It is a Class 1 Ophthalmic device (product code HNY) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K874993 · Advanced Surgical Products, Inc. · Ophthalmic device
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Apr 1988
Decision
133d
Days
Class 1
Risk

K874993 is an FDA 510(k) clearance for the PRISMA DISPOSABLE SHARP IRRIGATING 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

Submission Details

510(k) Number K874993 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.

Device Classification

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 7
Devices cleared under the same product code (HNY) and FDA review panel - the closest regulatory comparables to K874993.
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 STRAIGHT IRRIGATING CYSTOTOME
K874997 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K875001 · Advanced Surgical Products, Inc. · Apr 1988
DISPOSABLE CYSTOTOME
K831916 · CooperVision, Inc. · Jul 1983