Cleared Traditional

K970673 - DISPOSABLE VITRECTOMY PROBE

K970673 is an FDA 510(k) clearance for DISPOSABLE VITRECTOMY PROBE, manufactured by Altex Vision. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K970673 · Altex Vision · Ophthalmic device
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May 1997
Decision
70d
Days
Class 2
Risk

K970673 is an FDA 510(k) clearance for the DISPOSABLE VITRECTOMY PROBE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Altex Vision (San Francisco, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 70 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 Altex Vision devices

FDA 510(k) Submission Details - K970673

510(k) Number K970673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date May 05, 1997
Days to Decision 70 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
40d faster than avg
Panel avg: 110d · This submission: 70d
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 86
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K970673.
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K960061 · Storz Instrument Co. · Sep 1996
AUTOMATED VITRECTOMY DEVICE
K961078 · Promex, Inc. · Jun 1996