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GalaFORM 3D

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K162922

by Tepha, Inc.

Identity

Trade Name
GalaFORM 3D FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Device Name
GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. FDA UDI
Model / Reference
100043-06 FDA UDI
Description
GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. FDA UDI

Identifiers

Catalog Number
FR3D06 FDA UDI
Primary DI / UDI-DI
00855920006270 FDA UDI
510(k) Number
K162922 FDA 510(k)FDA UDI
FDA Product Code
OOD FDA 510(k)FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)FDA UDI
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Length — 21 Centimeter FDA UDI
Height — 7.5 Centimeter FDA UDI

GalaFORM 3D by Tepha, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tepha, Inc.

Sources (2)

  • FDA 510(k) K162922 24 fields · synced Jun 18, 2026
  • FDA UDI baa75343-83de-478b-bbd9-796287584be8 38 fields · synced May 27, 2026