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Namic 0247001

by Navilyst Medical, Inc.

Namic 0247001 is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K896108 on 9 Jan 1990 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI H74902470010), 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) K896108

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 NumberH74902470010 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK896108 Date9 Jan 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K896108 decided 9 Jan 1990 Active
  • FDA GUDID UDI-DI H74902470010 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K896108
  2. Listed FDA GUDID H74902470010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Namic
Generic name
Torque manipulation device
Model / reference
0247001
Primary DI / UDI-DI
H74902470010
510(k) Number
FDA product code
LOX
GMDN term
Torque manipulation device
Device class
Class II
Regulation number
870.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Torque manipulation device

Similar devices

Other devices filed under FDA product code LOX (Catheters, transluminal coronary angioplasty, percutaneous).

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)