Cleared Traditional

K905484 - ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT

K905484 · Mentor Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
67d
Days
-
Risk

K905484 is an FDA 510(k) clearance for the ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 67 days - a notably fast clearance 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: 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 Mentor Corp. devices

FDA 510(k) Submission Details - K905484

510(k) Number K905484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date February 11, 1991
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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 39
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K905484.
MAGNETIC PORT SILICONE TISSUE EXPANDER
K982067 · Specialty Surgical Products, Inc. · Jul 1998
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · Specialty Surgical Products, Inc. · Feb 1998
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
K903448 · Medical Engineering Corp. · Jan 1991
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · Mentor Corp. · Nov 1990
SURGITEK(R) EXTERNAL FILL PORT
K894495 · Surgitek · Jan 1990