Cleared Traditional

K982475 - SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL

K982475 is an FDA 510(k) clearance for SOFT TISSUE AUGMENTATION YUBE WITH INSE..., manufactured by Tissue Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K982475 · Tissue Technologies, Inc. · General & Plastic Surgery device
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Sep 1998
Decision
68d
Days
Class 2
Risk

K982475 is an FDA 510(k) clearance for the SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tissue Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 Tissue Technologies, Inc. devices

FDA 510(k) Submission Details - K982475

510(k) Number K982475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1998
Decision Date September 22, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 224
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K982475.
PARIETEX
K982532 · Cogent · Jan 1999
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K984197 · Bridger Biomed, Inc. · Jan 1999
MESH, SURGICAL, POLYMERIC
K982575 · United States Surgical, A Division of Tyco Healthc · Nov 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
K981756 · Shelhigh, Inc. · Aug 1998
SIS HERNIA REPAIR DEVICE
K974540 · Sentron Medical, Inc. · May 1998
HERNIAMESH SURGICAL MESHES
K973955 · Herniamesh · May 1998