Cleared Traditional

K891601 - POWER OPERATED AND CONTROLLED VITREOUS ...

K891601 is an FDA 510(k) clearance for POWER OPERATED AND CONTROLLED VITREOUS ..., manufactured by Mira, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K891601 · Mira, Inc. · Ophthalmic device
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May 1989
Decision
64d
Days
Class 2
Risk

K891601 is an FDA 510(k) clearance for the POWER OPERATED AND CONTROLLED VITREOUS SCISSORS. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on May 23, 1989 after a review of 64 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 Mira, Inc. devices

FDA 510(k) Submission Details - K891601

510(k) Number K891601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date May 23, 1989
Days to Decision 64 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
46d faster than avg
Panel avg: 110d · This submission: 64d
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 72
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K891601.
I/A HANDPIECE
K896754 · Advanced Surgical Products, Inc. · Jan 1990
MULTI-USE I/A HANDPIECE
K896305 · Advanced Surgical Products, Inc. · Dec 1989
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K894278 · Storz Instrument Co. · Aug 1989
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884557 · Advanced Surgical Products, Inc. · May 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300 · CooperVision, Inc. · Apr 1989
DREYER CURVED ENDOILLUMINATOR
K884556 · Advanced Surgical Products, Inc. · Feb 1989