Cleared Traditional

K810017 - MICROSURG CAUTERY

K810017 is an FDA 510(k) clearance for MICROSURG CAUTERY, manufactured by Medical Products Development, Inc.. The device is a Class 2 Ophthalmic device with product code HQO cleared through the Traditional 510(k) pathway .

K810017 · Medical Products Development, Inc. · Ophthalmic device
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Jan 1981
Decision
-
Days
Class 2
Risk

K810017 is an FDA 510(k) clearance for the MICROSURG CAUTERY. Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Medical Products Development, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1981.

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 Medical Products Development, Inc. devices

FDA 510(k) Submission Details - K810017

510(k) Number K810017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 05, 1981
Decision Date January 05, 1981
Days to Decision -
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQO Device Classification - Class 2, Special Controls

Product Code HQO Unit, Cautery, Thermal, Ac-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.