Cleared Traditional

K990930 - 3D ANATOMICAL MESH

K990930 is an FDA 510(k) clearance for 3D ANATOMICAL MESH, manufactured by Santerra Medical Technology, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K990930 · Santerra Medical Technology, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
90d
Days
Class 2
Risk

K990930 is an FDA 510(k) clearance for the 3D ANATOMICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Santerra Medical Technology, Inc. (Lake Elmo, US). The FDA issued a Cleared decision on June 17, 1999 after a review of 90 days - within the typical 510(k) review window.

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: 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 Santerra Medical Technology, Inc. devices

FDA 510(k) Submission Details - K990930

510(k) Number K990930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1999
Decision Date June 17, 1999
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K990930.
GORE-TEX DUALMESH BIOMATERIAL
K992189 · W.L. Gore & Associates, Inc. · Jul 1999
PARIETENE POLYPROPYLENE MESH
K991400 · Sofradim Production · Jul 1999
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
K991637 · Davol Inc., Sub. C. R. Bard, Inc. · Jun 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220 · Ethicon, Inc. · Feb 1999
PARIETEX
K982532 · Cogent · Jan 1999
FLUOROTEX SURGICAL MESH
K984197 · Bridger Biomed, Inc. · Jan 1999