Cleared Traditional

K781089 - ONE INCISION BI-POLAR ELECTRO. FORCEPS

K781089 is the FDA 510(k) clearance for ONE INCISION BI-POLAR ELECTRO. FORCEPS by Kli. It is a Class 2 Obstetrics & Gynecology device (product code HIN) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K781089 · Kli · Obstetrics & Gynecology device
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Jul 1978
Decision
18d
Days
Class 2
Risk

K781089 is an FDA 510(k) clearance for the ONE INCISION BI-POLAR ELECTRO. FORCEPS. Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Kli (Mchenry, US). The FDA issued a Cleared decision on July 17, 1978 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4150 - the FDA obstetrics and gynecology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K781089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1978
Decision Date July 17, 1978
Days to Decision 18 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d faster than avg
Panel avg: 160d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4150
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 Obstetrics & Gynecology devices follow this clearance model.