Cleared Traditional

K933907 - STORZ FIBEROPTIC PICK MANIPULATOR

K933907 is the FDA 510(k) clearance for STORZ FIBEROPTIC PICK MANIPULATOR by Storz Instrument Co.. It is a Class 2 Ophthalmic device (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

Submission Details

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.

Device Classification

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 47
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K933907.
INFINITECH ASPIRATING LASER PROBE
K946135 · Surgical Technologies, Inc. · Apr 1995
INFINITECH SOFT TIP FLUTE NEEDLE
K946181 · Surgical Technologies, Inc. · Mar 1995
NIDEK MODEL VT-4000, MODIFICATION
K936302 · Nidek, Inc. · Jul 1994
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
K933984 · Storz Instrument Co. · Jan 1994
BARE-FIBER ENDOILLUMINATOR
K933208 · Surgical Technologies, Inc. · Dec 1993
NIDEK MODEL VST-4000
K924353 · Nidek, Inc. · Mar 1993