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Assi 4230BPD

by Accurate Surgical & Scientific Instruments Corp.

Assi 4230BPD is a Class II device made by Accurate Surgical & Scientific Instruments Corp., cleared under FDA 510(k) K900533 on 9 Apr 1990 and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00841645140801), 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) K900533

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 Number00841645140801 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK900533 Date9 Apr 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K900533 decided 9 Apr 1990 Active
  • FDA GUDID UDI-DI 00841645140801 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K900533
  2. Listed FDA GUDID 00841645140801

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Assi
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Model / reference
4230BPD
Description
Disposable. BP Fcps, Jewelers Str. Tip, 10.2cm, 0.5mm Tip 10/box
Primary DI / UDI-DI
00841645140801
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Other devices from Accurate Surgical & Scientific Instruments Corp.

See all devices from Accurate Surgical & Scientific Instruments Corp. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)