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Ran-11

by Ranfac Corp.

Ran-11 is a Class II device made by Ranfac Corp., cleared under FDA 510(k) K131157 on 22 Oct 2013, registered in EUDAMED and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 00858690006396), active as of 10 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131157

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00858690006396 UDI-DI Date9 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK131157 Date22 Oct 2013IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K131157 decided 22 Oct 2013 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 00858690006396 listed 9 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131157
  2. Listed FDA GUDID 00858690006396

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Bone access cannula
Model / Ref / Catalog
RAN-11
Description
RAN-11 BLUE F/G, STERILE, K2M P/N 74192-01M
Primary DI / UDI-DI
00858690006396
510(k) Number
FDA product code
KNW
GMDN term
Bone access cannula
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 11 Gauge
Length — 11 Centimeter

Related devices

Category: Bone access cannula

Cleared under the same submission (K131157)

and 8 more cleared under K131157

Similar devices

Other devices filed under FDA product code KNW (Instrument, Biopsy).

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)