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Exodus 10512

by Navilyst Medical, Inc.

Exodus 10512 is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K152069 on 24 Sep 2015 and listed in FDA GUDID since 5 Aug 2016 (UDI-DI H965105120), 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) K152069

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 NumberH965105120 UDI-DI Date5 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152069 Date24 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152069 decided 24 Sep 2015 Active
  • FDA GUDID UDI-DI H965105120 listed 5 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152069
  2. Listed FDA GUDID H965105120

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Exodus
Generic name
Closed-wound drain, non-bioabsorbable
Model / reference
10512
Primary DI / UDI-DI
H965105120
510(k) Number
FDA product code
FGE
GMDN term
Closed-wound drain, non-bioabsorbable
Device class
Class II
Regulation number
876.5010
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 3.4 Millimeter
Catheter Gauge — 10 French
Length — 35 Centimeter

Related devices

Category: Closed-wound drain, non-bioabsorbable

Cleared under the same submission (K152069)

and 8 more cleared under K152069

Similar devices in this category

Other devices filed under Closed-wound drain, non-bioabsorbable.

Other devices from Navilyst Medical, Inc.

See all devices from Navilyst Medical, Inc. →

Properties

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