Cleared Traditional

K882103 - SITE ULTRASONIC I/A PHACO NEEDLE

K882103 is an FDA 510(k) clearance for SITE ULTRASONIC I/A PHACO NEEDLE, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K882103 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Jul 1988
Decision
43d
Days
Class 2
Risk

K882103 is an FDA 510(k) clearance for the SITE ULTRASONIC I/A PHACO NEEDLE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 43 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Site Microsurgical Systems, Inc. devices

FDA 510(k) Submission Details - K882103

510(k) Number K882103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date July 01, 1988
Days to Decision 43 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
67d faster than avg
Panel avg: 110d · This submission: 43d
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 195
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K882103.
STAAR PHACO XL SMALL INCISION SYSTEM
K884241 · Staar Surgical Co. · Feb 1989
SITE MACROBORE PHACO NEEDLE
K883099 · Site Microsurgical Systems, Inc. · Sep 1988
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
K883199 · Chiron Vision Corp. · Sep 1988
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K871854 · CooperVision, Inc. · Jul 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K871485 · Site Microsurgical Systems, Inc. · Jun 1987
I/A/KPE TIP
K864726 · Ipax, Inc. · Jan 1987