Cleared Traditional

K790577 - HEMORRHOIDAL LIGATOR

K790577 is an FDA 510(k) clearance for HEMORRHOIDAL LIGATOR, manufactured by J. Sklar Mfg. Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code HCF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K790577 · J. Sklar Mfg. Co., Inc. · General & Plastic Surgery device
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Apr 1979
Decision
26d
Days
Class 1
Risk

K790577 is an FDA 510(k) clearance for the HEMORRHOIDAL LIGATOR. Classified as Instrument, Ligature Passing And Knot Tying (product code HCF), Class I - General Controls.

Submitted by J. Sklar Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1979 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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.

View all J. Sklar Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K790577

510(k) Number K790577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1979
Decision Date April 23, 1979
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

HCF Device Classification - Class 1, General Controls

Product Code HCF Instrument, Ligature Passing And Knot Tying
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.