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Assi 102002BPIS

by Accurate Surgical & Scientific Instruments Corp.

Assi 102002BPIS is a Class II device made by Accurate Surgical & Scientific Instruments Corp., cleared under FDA 510(k) K811820 on 28 Jul 1981 and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00841645100126), 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) K811820

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 Number00841645100126 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK811820 Date28 Jul 1981DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K811820 decided 28 Jul 1981 Active
  • FDA GUDID UDI-DI 00841645100126 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K811820
  2. Listed FDA GUDID 00841645100126

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  • Withdrawn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, reusable
Model / reference
102002BPIS
Description
Cushing BP Fcps Insl. 18cm, Str. Tip Dia. 0.7mm
Primary DI / UDI-DI
00841645100126
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Accurate Surgical & Scientific Instruments Corp.

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

Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)