Cleared Traditional

K895212 - TIK EXTRAKTOR

K895212 is an FDA 510(k) clearance for TIK EXTRAKTOR, manufactured by Instruments of Sweden, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTD cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K895212 · Instruments of Sweden, Inc. · General & Plastic Surgery device
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Sep 1989
Decision
40d
Days
Class 1
Risk

K895212 is an FDA 510(k) clearance for the TIK EXTRAKTOR. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by Instruments of Sweden, Inc. (Stamford, US). The FDA issued a Cleared decision on September 27, 1989 after a review of 40 days - a notably fast clearance cycle.

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: 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 Instruments of Sweden, Inc. devices

FDA 510(k) Submission Details - K895212

510(k) Number K895212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1989
Decision Date September 27, 1989
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

HTD Device Classification - Class 1, General Controls

Product Code HTD Forceps
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 - HTD Forceps

All 63
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K895212.
CUSHING BAYONET, INSULATED BIPOLAR FORCEP
K974595 · Titan Mfg., Inc. · Jun 1998
MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS
K913964 · Marlo Surgical Technology · Oct 1991
CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS
K911180 · Northgate Technologies, Inc. · Mar 1991
GALL STONE FORCEPS
K890369 · Kinetic Medical Products · Feb 1989
HEMORRHOIDAL FORCEPS
K890373 · Kinetic Medical Products · Feb 1989
MICROSURGICAL FORCEPS
K890213 · Kinetic Medical Products · Jan 1989