Cleared Traditional

K946181 - INFINITECH SOFT TIP FLUTE NEEDLE

K946181 is an FDA 510(k) clearance for INFINITECH SOFT TIP FLUTE NEEDLE, manufactured by Surgical Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K946181 · Surgical Technologies, Inc. · Ophthalmic device
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Mar 1995
Decision
84d
Days
Class 2
Risk

K946181 is an FDA 510(k) clearance for the INFINITECH SOFT TIP FLUTE NEEDLE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Surgical Technologies, Inc. (Chesterfield, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 Surgical Technologies, Inc. devices

FDA 510(k) Submission Details - K946181

510(k) Number K946181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date March 14, 1995
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 92
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K946181.
STORZ MVS-3201 VITRECTOMY PROBE PACK
K953575 · Storz Instrument Co. · Sep 1995
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
K953576 · Storz Instrument Co. · Sep 1995
INFINITECH ASPIRATING LASER PROBE
K946135 · Surgical Technologies, Inc. · Apr 1995
MICRODRIVE
K934600 · Medical Instrument Development Laboratories, Inc. · Jul 1994
NIDEK MODEL VT-4000, MODIFICATION
K936302 · Nidek, Inc. · Jul 1994
PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
K940391 · Peregrine Surgical , Ltd. · Jun 1994