Cleared Traditional

K875260 - EFFNER CAUTERY INSTRUMENTS

K875260 is an FDA 510(k) clearance for EFFNER CAUTERY INSTRUMENTS, manufactured by Effner and Spreine Co.. The device is a Class 2 Ophthalmic device with product code HQP cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K875260 · Effner and Spreine Co. · Ophthalmic device
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Jun 1988
Decision
167d
Days
Class 2
Risk

K875260 is an FDA 510(k) clearance for the EFFNER CAUTERY INSTRUMENTS. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Effner and Spreine Co. (Port Washington, US). The FDA issued a Cleared decision on June 6, 1988 after a review of 167 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - 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 Effner and Spreine Co. devices

FDA 510(k) Submission Details - K875260

510(k) Number K875260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date June 06, 1988
Days to Decision 167 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 110d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQP Device Classification - Class 2, Special Controls

Product Code HQP Unit, Cautery, Thermal, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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 - HQP Unit, Cautery, Thermal, Battery-powered

All 16
Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K875260.
LOW TEMPERATURE CAUTERY ELONGATED FINE TIP
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OPHTHALMIC CAUTERY
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ELECTROCAUTERY SYSTEM MODEL 1980
K933079 · Pmt Corp. · Feb 1994
OPTHERM FINE TIP
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OPTHERM EXTRA FINE TIP
K840426 · Suncoast Medical Manufacturers, Inc. · May 1984
REPLACE-A-TIP RECHARG. LOW TEMP.
K841325 · Suncoast Medical Manufacturers, Inc. · May 1984