Cleared Traditional

K941495 - RETURN PATH DIATHERMY HANDLE

K941495 is an FDA 510(k) clearance for RETURN PATH DIATHERMY HANDLE, manufactured by Mira, Inc.. The device is a Class 2 Ophthalmic device with product code HQR cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K941495 · Mira, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
109d
Days
Class 2
Risk

K941495 is an FDA 510(k) clearance for the RETURN PATH DIATHERMY HANDLE. Classified as Apparatus, Cautery, Radiofrequency, Ac-powered (product code HQR), Class II - Special Controls.

Submitted by Mira, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 15, 1994 after a review of 109 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K941495

510(k) Number K941495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1994
Decision Date July 15, 1994
Days to Decision 109 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
1d faster than avg
Panel avg: 110d · This submission: 109d
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 9
Devices cleared under the same product code (HQR) and FDA review panel - the closest regulatory comparables to K941495.
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MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
K934320 · Mentor O & O, Inc. · Feb 1994
ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
K895800 · Advanced Surgical Products, Inc. · Jan 1990