Cleared Traditional

K952151 - STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)

K952151 is an FDA 510(k) clearance for STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRU..., manufactured by Storz. The device is a Class 2 Ophthalmic device with product code HQR cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K952151 · Storz · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
301d
Days
Class 2
Risk

K952151 is an FDA 510(k) clearance for the STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLA.... Classified as Apparatus, Cautery, Radiofrequency, Ac-powered (product code HQR), Class II - Special Controls.

Submitted by Storz (St. Louis, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - 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. Elevated predicate reliance profile. 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 devices

FDA 510(k) Submission Details - K952151

510(k) Number K952151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date March 04, 1996
Days to Decision 301 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
191d slower than avg
Panel avg: 110d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQR Device Classification - Class 2, Special Controls

Product Code HQR Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
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 - HQR Apparatus, Cautery, Radiofrequency, Ac-powered

All 7
Devices cleared under the same product code (HQR) and FDA review panel - the closest regulatory comparables to K952151.
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
K990064 · Ophthalmic Technologies, Inc. · Apr 1999
REFRACTEC MCS-100
K980522 · Refractec, Inc. · Jul 1998
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
K972749 · C.M. Chance , Ltd. · Mar 1998
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
K952569 · Gamp & Assoc. · Jan 1996
RETURN PATH DIATHERMY HANDLE
K941495 · Mira, Inc. · Jul 1994
MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
K934320 · Mentor O & O, Inc. · Feb 1994