Skip to content

Fibrijet SA-3768

by Micromedics, Inc.

Fibrijet SA-3768, an open-surgery adhesive/sealant applicator (FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Micromedics, Inc., was cleared under FDA 510(k) K122526 on 16 Nov 2012 and listed in FDA GUDID on 13 Jan 2017 (UDI-DI 00815634020504); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K122526

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815634020504 UDI-DI Date13 Jan 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK122526 Date16 Nov 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122526 decided 16 Nov 2012 Active
  • FDA GUDID UDI-DI 00815634020504 listed 13 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122526
  2. Listed FDA GUDID 00815634020504

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fibrijet
Generic name
Open-surgery adhesive/sealant applicator, dual-channel
Model / reference
SA-3768
Primary DI / UDI-DI
00815634020504
510(k) Number
FDA product code
GCJ
GMDN term
Open-surgery adhesive/sealant applicator, dual-channel
Device class
Class II
Regulation number
876.1500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K122526)

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)