Cleared Traditional

K903448 - SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER

K903448 · Medical Engineering Corp. · General & Plastic Surgery device
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Jan 1991
Decision
167d
Days
-
Risk

K903448 is an FDA 510(k) clearance for the SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Medical Engineering Corp. (Paso Robles, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 167 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 Medical Engineering Corp. devices

FDA 510(k) Submission Details - K903448

510(k) Number K903448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date January 14, 1991
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
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 K903448.
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · Specialty Surgical Products, Inc. · Feb 1998
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · Mentor Corp. · Feb 1991
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · Mentor Corp. · Nov 1990
SURGITEK(R) EXTERNAL FILL PORT
K894495 · Surgitek · Jan 1990
SURGITEK FLAT T-SPAN
K884746 · Medical Engineering Corp. · Aug 1989