Cleared Traditional

K874991 - PRISMA DISPOSABLE IRRIGATING IRIS HOOK

K874991 is an FDA 510(k) clearance for PRISMA DISPOSABLE IRRIGATING IRIS HOOK, manufactured by Advanced Surgical Products, Inc.. The device is a Class 1 Ophthalmic device with product code HNQ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K874991 · Advanced Surgical Products, Inc. · Ophthalmic device
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Apr 1988
Decision
133d
Days
Class 1
Risk

K874991 is an FDA 510(k) clearance for the PRISMA DISPOSABLE IRRIGATING IRIS HOOK. Classified as Hook, Ophthalmic (product code HNQ), 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 - K874991

510(k) Number K874991 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.

HNQ Device Classification - Class 1, General Controls

Product Code HNQ Hook, 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 - HNQ Hook, Ophthalmic

Devices cleared under the same product code (HNQ) and FDA review panel - the closest regulatory comparables to K874991.
LOOK LENS LOOPS
K870440 · Look, Inc. · Feb 1987
THORTON TITANIUM HOOK ANGLED RIGHT
K863988 · Keeler Instruments, Inc. · Oct 1986
BONN MICRO IRIS HOOK (NON-STERILE) #7613
K801469 · Edward Weck, Inc. · Jul 1980
HOOKS #'S 7600,7602,7603,7616
K791985 · Edward Weck, Inc. · Oct 1979
HOOK, IRIS, SHEPARD U-SHAPED
K770103 · Edward Weck, Inc. · Jan 1977
HOOK, IRIS, HERSHMAN
K770098 · Edward Weck, Inc. · Jan 1977