Cleared Traditional

K923630 - PHACO NEEDLES 1000-R & 1000-O NEEDLES

K923630 is an FDA 510(k) clearance for PHACO NEEDLES 1000-R & 1000-O NEEDLES, manufactured by O.R. Specialties, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 624-day FDA review.

K923630 · O.R. Specialties, Inc. · Ophthalmic device
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Apr 1994
Decision
624d
Days
Class 2
Risk

K923630 is an FDA 510(k) clearance for the PHACO NEEDLES 1000-R & 1000-O NEEDLES. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on April 6, 1994 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 O.R. Specialties, Inc. devices

FDA 510(k) Submission Details - K923630

510(k) Number K923630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date April 06, 1994
Days to Decision 624 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
514d slower than avg
Panel avg: 110d · This submission: 624d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 198
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