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General Purpose Support strap 65

by Neocoil, LLC

General Purpose Support strap 65 is a Class II device made by Neocoil, LLC, cleared under FDA 510(k) K113474 on 16 Mar 2012 and listed in FDA GUDID since 16 Mar 2017 (UDI-DI 00856181003657), active as of 22 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 22 Oct 2026

Documents

510(k) K113474

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 Number00856181003657 UDI-DI Date16 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK113474 Date16 Mar 2012IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113474 decided 16 Mar 2012 Active
  • FDA GUDID UDI-DI 00856181003657 listed 16 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113474
  2. Listed FDA GUDID 00856181003657

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
General Purpose Support strap
Generic name
MRI system coil, radio-frequency
Model / reference
65
Primary DI / UDI-DI
00856181003657
510(k) Number
FDA product code
MOS
GMDN term
MRI system coil, radio-frequency
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system coil, radio-frequency

Cleared under the same submission (K113474)

and 8 more cleared under K113474

Similar devices in this category

Other devices filed under MRI system coil, radio-frequency.

Other devices from Neocoil, LLC

See all devices from Neocoil, LLC →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)