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AccuPlan System MC-K041

by Medcad

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) K223421

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810007631554 UDI-DI Date1 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223421 Date20 Sep 2023DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AccuPlan System
Generic name
Custom-made organ/bone anatomy model/surgical guide kit
Model / Ref / Catalog
MC-K041
Primary DI / UDI-DI
00810007631554
510(k) Number
FDA product code
LLZ, PBF
GMDN term
Custom-made organ/bone anatomy model/surgical guide kit
Device class
Class II
Regulation number
892.2050, 888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Custom-made organ/bone anatomy model/surgical guide kit

Cleared under the same submission (K223421)

Show all (9)

Other devices from Medcad

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number

Other properties (10)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No
  • Manufacturing date: No