Cleared Traditional

SINGLE HAIR TRANSPLANT GRAFT (K841741) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K841741 · Paris Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
91d
Days
Class 1
Risk

K841741 is an FDA 510(k) clearance for the SINGLE HAIR TRANSPLANT GRAFT. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by Paris Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 23, 1984 after a review of 91 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 Paris Products, Inc. devices

Submission Details

510(k) Number K841741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date July 23, 1984
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZT Cutter, 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.

Regulatory Peers - FZT Cutter, Surgical

All 29
Devices cleared under the same product code (FZT) and FDA review panel - the closest regulatory comparables to K841741.
AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
K890818 · United States Surgical, A Division of Tyco Healthc · May 1989
SURGICAL SCISSORS, SET OF 3
K821632 · Fred Sammons, Inc. · Jun 1982
CONPHAR WIRE CUTTING SCISSORS
K821350 · Conphar, Inc. · May 1982
CONPHAR DISSECTING SCISSORS
K821351 · Conphar, Inc. · May 1982
CONPHAR IRIS SCISSORS
K821352 · Conphar, Inc. · May 1982
CONPHAR LITTAUER SCISSORS
K821355 · Conphar, Inc. · May 1982