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Pronova 3861H

by Ethicon Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031004900 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Pronova
Generic Name
Polyvinylidene fluoride suture
Model / Ref / Catalog
3861H
Primary DI / UDI-DI
10705031004900
510(k) Number
FDA Product Code
GAW
GMDN Term
Polyvinylidene fluoride suture
Device Class
Class II
Regulation Number
878.5010
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K001625)

Show all (12)

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No