Cleared Traditional

K894495 - SURGITEK(R) EXTERNAL FILL PORT

K894495 · Surgitek · General & Plastic Surgery device
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Jan 1990
Decision
182d
Days
-
Risk

K894495 is an FDA 510(k) clearance for the SURGITEK(R) EXTERNAL FILL PORT. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on January 17, 1990 after a review of 182 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Surgitek devices

FDA 510(k) Submission Details - K894495

510(k) Number K894495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1989
Decision Date January 17, 1990
Days to Decision 182 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
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

LCJ Device Classification - Class 0,

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 26
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K894495.
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · Mentor Corp. · Feb 1991
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
K903448 · Medical Engineering Corp. · Jan 1991
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · Mentor Corp. · Nov 1990
SURGITEK FLAT T-SPAN
K884746 · Medical Engineering Corp. · Aug 1989
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · Mentor Corp. · Jun 1989
MENTOR FLAT-SPAN
K862049 · Mentor Corp. · Jun 1986