Cleared Traditional

K852075 - SITE-MALIS BIPOLAR COAGULATOR MODULE

K852075 is an FDA 510(k) clearance for SITE-MALIS BIPOLAR COAGULATOR MODULE, manufactured by Valley Forge Scientific Corp.. The device is a Class 2 Ophthalmic device with product code HQO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K852075 · Valley Forge Scientific Corp. · Ophthalmic device
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Aug 1985
Decision
99d
Days
Class 2
Risk

K852075 is an FDA 510(k) clearance for the SITE-MALIS BIPOLAR COAGULATOR MODULE. Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 99 days - within the typical 510(k) review window.

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 Valley Forge Scientific Corp. devices

FDA 510(k) Submission Details - K852075

510(k) Number K852075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date August 20, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
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.