Cleared Traditional

K920718 - DISPOSABLE POSTERIOR MICROSCISSORS

K920718 is an FDA 510(k) clearance for DISPOSABLE POSTERIOR MICROSCISSORS, manufactured by Storz Instrument Co.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920718 · Storz Instrument Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
90d
Days
Class 2
Risk

K920718 is an FDA 510(k) clearance for the DISPOSABLE POSTERIOR MICROSCISSORS. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on May 18, 1992 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Storz Instrument Co. devices

FDA 510(k) Submission Details - K920718

510(k) Number K920718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date May 18, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K920718.
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
K924604 · Storz Instrument Co. · Nov 1992
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
K921758 · Storz Instrument Co. · Jul 1992
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
K921460 · Storz Instrument Co. · Jul 1992
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
K920582 · Site Microsurgical Systems, Inc. · May 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K915745 · Storz Instrument Co. · Mar 1992
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
K912384 · Nidek, Inc. · Dec 1991