Skip to content

Cbn-114 11GA X 4"

by Ranfac Corp.

Cbn-114 11GA X 4" is a Class II device made by Ranfac Corp., cleared under FDA 510(k) K183146 on 25 Apr 2019 and listed in FDA GUDID since 31 Jul 2019 (UDI-DI 00857878007644), 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) K183146

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 Number00857878007644 UDI-DI Date31 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183146 Date25 Apr 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183146 decided 25 Apr 2019 Active
  • FDA GUDID UDI-DI 00857878007644 listed 31 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K183146
  2. Listed FDA GUDID 00857878007644

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cbn-114
Generic name
Bone marrow biopsy needle, single-use
Model / Ref / Catalog
11GA X 4", CBN-114
Description
Cartilage Biopsy Needle, CBN-114 PN 74328-01M Customer #: 0013091
Primary DI / UDI-DI
00857878007644
510(k) Number
FDA product code
KNW
GMDN term
Bone marrow biopsy needle, single-use
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 11 Gauge
Length — 4 Inch

Similar devices in this category

Other devices filed under Bone marrow biopsy needle, single-use.

Other devices from Ranfac Corp.

See all devices from Ranfac Corp. →

Properties

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