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Wire Pass Drill 800-330

by Acra-Cut Inc

Wire Pass Drill 800-330 is a cranial trephine (FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Acra-Cut Inc, cleared under FDA 510(k) K911812 on 10 Sep 1991 and listed in FDA GUDID since 1 May 2017 (UDI-DI 00810607000439), 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) K911812

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 Number00810607000439 UDI-DI Date1 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK911812 Date10 Sep 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K911812 decided 10 Sep 1991 Active
  • FDA GUDID UDI-DI 00810607000439 listed 1 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K911812
  2. Listed FDA GUDID 00810607000439

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Wire Pass Drill
Generic name
Cranial trephine, single-use
Model / Ref / Catalog
800-330
Primary DI / UDI-DI
00810607000439
510(k) Number
FDA product code
HBE
GMDN term
Cranial trephine, single-use
Device class
Class II
Regulation number
882.4310
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Cranial trephine, single-use

Cleared under the same submission (K911812)

Similar devices

Other devices filed under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)).

Other devices from Acra-Cut Inc

See all devices from Acra-Cut Inc →

Properties

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