Cleared Traditional

K991296 - TUTOPATCH

K991296 is an FDA 510(k) clearance for TUTOPATCH, manufactured by Tutogen Medical U.S., Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 540-day FDA review.

K991296 · Tutogen Medical U.S., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
540d
Days
Class 2
Risk

K991296 is an FDA 510(k) clearance for the TUTOPATCH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Tutogen Medical U.S., Inc. (Alachua, US). The FDA issued a Cleared decision on October 6, 2000 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Tutogen Medical U.S., Inc. devices

FDA 510(k) Submission Details - K991296

510(k) Number K991296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1999
Decision Date October 06, 2000
Days to Decision 540 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
425d slower than avg
Panel avg: 115d · This submission: 540d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 92
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K991296.
DERMMATRIX SURGICAL MESH
K021160 · Carbon Medical Technologies, Inc. · Jun 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · Tei Biosciences, Inc. · Apr 2002
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc. · Dec 2000
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
K992537 · Bio-Vascular, Inc. · Feb 2000
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
K991567 · Shelhigh, Inc. · Jul 1999
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
K983162 · Bio-Vascular, Inc. · Oct 1998