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Megasorb MS2869

by Meril Endo Surgery Private Limited

Megasorb MS2869 is a skin-closing tension device (FDA Class II; FDA product code GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid) made by Meril Endo Surgery Private Limited, cleared under FDA 510(k) K172659 on 28 Sep 2017 and listed in FDA GUDID since 21 Sep 2020 (UDI-DI 08904255211476), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K172659

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08904255211476 UDI-DI Date21 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK172659 Date28 Sep 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172659 decided 28 Sep 2017 Active
  • FDA GUDID UDI-DI 08904255211476 listed 21 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172659
  2. Listed FDA GUDID 08904255211476

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Megasorb
Generic name
Skin-closing tension device
Model / Ref / Catalog
MS2869
Description
Braided coated Polyglycolic Acid Surgical Suture USP
Primary DI / UDI-DI
08904255211476
510(k) Number
FDA product code
GAM
GMDN term
Skin-closing tension device
Device class
Class II
Regulation number
878.4493
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).

Other devices from Meril Endo Surgery Private Limited

See all devices from Meril Endo Surgery Private Limited →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)