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Reli R-MCN22

by Myco Medical Supplies Inc.

Reli R-MCN22 is a Class II device made by Myco Medical Supplies Inc., cleared under FDA 510(k) K051506 on 27 Jul 2005 and listed in FDA GUDID since 11 Sep 2018 (UDI-DI 00386120008110), 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) K051506

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 Number00386120008110 UDI-DI Date11 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK051506 Date27 Jul 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051506 decided 27 Jul 2005 Active
  • FDA GUDID UDI-DI 00386120008110 listed 11 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K051506
  2. Listed FDA GUDID 00386120008110

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Reli
Generic name
Bone marrow biopsy procedure kit
Model / Ref / Catalog
R-MCN22
Primary DI / UDI-DI
00386120008110
510(k) Number
FDA product code
KNW, FCG
GMDN term
Bone marrow biopsy procedure kit
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 15 Gauge

Similar devices in this category

Other devices filed under Bone marrow biopsy procedure kit.

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Properties

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