Cleared Traditional

K963066 - MENTOR INJECTION PORT DETECTOR (IPD)

K963066 · Mentor Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
51d
Days
-
Risk

K963066 is an FDA 510(k) clearance for the MENTOR INJECTION PORT DETECTOR (IPD). Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on September 27, 1996 after a review of 51 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 - K963066

510(k) Number K963066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date September 27, 1996
Days to Decision 51 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
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 K963066.
SILIMED TISSUE EXPANDER
K981852 · Silimed, LLC · Aug 1998
MAGNETIC PORT SILICONE TISSUE EXPANDER
K982067 · Specialty Surgical Products, Inc. · Jul 1998
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · Specialty Surgical Products, Inc. · Feb 1998
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