Cleared Traditional

K930113 - KIRWAN IRRIGATION/ASPIRATION HANDPIECE

K930113 is an FDA 510(k) clearance for KIRWAN IRRIGATION/ASPIRATION HANDPIECE, manufactured by Kirwan Surgical Products, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 402-day FDA review.

K930113 · Kirwan Surgical Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
402d
Days
Class 1
Risk

K930113 is an FDA 510(k) clearance for the KIRWAN IRRIGATION/ASPIRATION HANDPIECE. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Kirwan Surgical Products, Inc. (Rockland, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Kirwan Surgical Products, Inc. devices

FDA 510(k) Submission Details - K930113

510(k) Number K930113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1993
Decision Date February 17, 1994
Days to Decision 402 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
292d slower than avg
Panel avg: 110d · This submission: 402d
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 K930113.
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
K970873 · American Medical Devices, Inc. · May 1997
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
K921488 · Surgical Technologies, Inc. · May 1992
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 DISPOSABLE KRATZ CAPSULE POLISHER
K874969 · Advanced Surgical Products, Inc. · Apr 1988