Cleared Traditional

K780989 - DEVIN-NESTOR SQUARE KNIFE

K780989 is an FDA 510(k) clearance for DEVIN-NESTOR SQUARE KNIFE, manufactured by Nestor Engineering Associates, Inc.. The device is a Class 1 General & Plastic Surgery device with product code EMF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K780989 · Nestor Engineering Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
111d
Days
Class 1
Risk

K780989 is an FDA 510(k) clearance for the DEVIN-NESTOR SQUARE KNIFE. Classified as Knife, Surgical (product code EMF), Class I - General Controls.

Submitted by Nestor Engineering Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Nestor Engineering Associates, Inc. devices

FDA 510(k) Submission Details - K780989

510(k) Number K780989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1978
Decision Date October 03, 1978
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

EMF Device Classification - Class 1, General Controls

Product Code EMF Knife, Surgical
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.