Cleared Traditional

K933907 - STORZ FIBEROPTIC PICK MANIPULATOR

K933907 is an FDA 510(k) clearance for STORZ FIBEROPTIC PICK MANIPULATOR, 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 208-day FDA review.

K933907 · Storz Instrument Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
208d
Days
Class 2
Risk

K933907 is an FDA 510(k) clearance for the STORZ FIBEROPTIC PICK MANIPULATOR. 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 March 7, 1994 after a review of 208 days - an extended review 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: 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 - K933907

510(k) Number K933907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date March 07, 1994
Days to Decision 208 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
98d slower than avg
Panel avg: 110d · This submission: 208d
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 K933907.
NIDEK MODEL VT-4000, MODIFICATION
K936302 · Nidek, Inc. · Jul 1994
PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
K940391 · Peregrine Surgical , Ltd. · Jun 1994
SUPRA-VIT(TM)
K932669 · Medical Instrument Development Laboratories, Inc. · Jun 1994
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
K932668 · Synergetics, Inc. · Feb 1994
INTERTIP INFUSION SET
K934204 · Oasis Medical, Inc. · Feb 1994
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
K933984 · Storz Instrument Co. · Jan 1994