Cleared Traditional

K770970 - HAIR TRANSPLANT PUNCH, MULTIPLH

K770970 is an FDA 510(k) clearance for HAIR TRANSPLANT PUNCH, manufactured by Padgett Instruments, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAH cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K770970 · Padgett Instruments, Inc. · General & Plastic Surgery device
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Oct 1977
Decision
149d
Days
Class 1
Risk

K770970 is an FDA 510(k) clearance for the HAIR TRANSPLANT PUNCH, MULTIPLH. Classified as Stylet, Surgical, General & Plastic Surgery (product code GAH), Class I - General Controls.

Submitted by Padgett Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1977 after a review of 149 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 Padgett Instruments, Inc. devices

FDA 510(k) Submission Details - K770970

510(k) Number K770970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1977
Decision Date October 27, 1977
Days to Decision 149 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
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

GAH Device Classification - Class 1, General Controls

Product Code GAH Stylet, Surgical, General & Plastic Surgery
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.