Cleared Traditional

K930675 - MITEK CONE WASHER

K930675 is an FDA 510(k) clearance for MITEK CONE WASHER, manufactured by Mitek Surgical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGS cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K930675 · Mitek Surgical Products, Inc. · General & Plastic Surgery device
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Nov 1993
Decision
273d
Days
Class 1
Risk

K930675 is an FDA 510(k) clearance for the MITEK CONE WASHER. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on November 9, 1993 after a review of 273 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4930 - 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 Mitek Surgical Products, Inc. devices

FDA 510(k) Submission Details - K930675

510(k) Number K930675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1993
Decision Date November 09, 1993
Days to Decision 273 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 115d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

KGS Device Classification - Class 1, General Controls

Product Code KGS Retention Device, Suture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4930
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 - KGS Retention Device, Suture

All 13
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K930675.
RBM
K020480 · Smith & Nephew, Inc. · Mar 2002
SUTURE LOCK
K964935 · Smith & Nephew Endoscopy, Inc. · Feb 1997
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · Acufex Microsurgical, Inc. · Jun 1995
VENTROFIL TENSION RELIEF SUTURE SET
K904435 · Aesculap, Inc. · Aug 1991
SURGICAL RETENTION BAR
K902001 · Acufex Microsurgical, Inc. · May 1990
ACUFEX FIXATION BUTTON
K896310 · Acufex Microsurgical, Inc. · Nov 1989