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Gel-Syn Acid, Hyaluronic, Intraarticular

by Ibsa Institut Biochimique SA PMA

Active United States

PMA P110005

Overview

Gel-Syn is an intraarticular hyaluronic acid preparation, classified as a Class III medical device under FDA regulations. It is designed to provide intraarticular lubrication and cushioning in the knee joint, intended for patients with osteoarthritis who have not responded adequately to conservative therapies and simple analgesics.

This sterile, single-use device is administered via intraarticular injection for symptomatic relief of osteoarthritis pain. Supplied in pre-filled syringes, it requires aseptic handling and refrigeration prior to use. The product holds a Premarket Approval (PMA) from the FDA under PMA number P110005, with multiple FEI numbers registered under the generic name ‘Acid, Hyaluronic, Intraarticular’.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP110005 Date9 May 2014ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

PMA

Full name
Gel-Syn™
Trade Name
Sinovial (Sodium Hyaluronate 0.8%)
Generic Name
Acid, hyaluronic, intraarticular
PMA Number
FDA Product Code
MOZ
Device Class
Class III
Advisory Committee
Orthopedic
FDA Decision
APPR Approved