Cleared Traditional

K875001 - PRISMA DISPOSABLE BLUNT IRRIGATING CYST...

K875001 is the FDA 510(k) clearance for PRISMA DISPOSABLE BLUNT 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 131-day FDA review.

K875001 · Advanced Surgical Products, Inc. · Ophthalmic device
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Apr 1988
Decision
131d
Days
Class 1
Risk

K875001 is an FDA 510(k) clearance for the PRISMA DISPOSABLE BLUNT 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 131 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 K875001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date April 13, 1988
Days to Decision 131 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
21d slower than avg
Panel avg: 110d · This submission: 131d
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 K875001.
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
DISPOSABLE CYSTOTOME
K831916 · CooperVision, Inc. · Jul 1983
CYSTOTOMES
K790244 · Visitec Co. · Feb 1979