Cleared Traditional

K904436 - QUICKANCHOR (TM)

K904436 is the FDA 510(k) clearance for QUICKANCHOR (TM) by Mitek Surgical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAS) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K904436 · Mitek Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
74d
Days
Class 2
Risk

K904436 is an FDA 510(k) clearance for the QUICKANCHOR (TM). Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on December 11, 1990 after a review of 74 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Mitek Surgical Products, Inc. devices

Submission Details

510(k) Number K904436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1990
Decision Date December 11, 1990
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAS Suture, Nonabsorbable, Synthetic, Polyester

All 9
Devices cleared under the same product code (GAS) and FDA review panel - the closest regulatory comparables to K904436.
MITEK QUICKANCHOR(TM), MODIFICATION
K915089 · Mitek Surgical Products, Inc. · Feb 1992
MITEK SNAP PAK(TM), MODIFICATION
K915081 · Mitek Surgical Products, Inc. · Jan 1992
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
K905440 · United States Surgical, A Division of Tyco Healthc · Jan 1991
NONABSORBABLE DACRON SURGICAL SUTURE*
K902873 · United States Surgical, A Division of Tyco Healthc · Sep 1990