Assi 121030BP

by Accurate Surgical & Scientific Instruments Corp.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841645100515 UDI-DI	Date25 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK811820	Date28 Jul 1981Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00841645100515
FDA 510(k) database 510(k) number K811820

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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Withdrawn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: 121030BP
Description: Hardy Type Bayonet BP Fcps., Str. 21cm,Tip 0.5mm Dia.

Primary DI / UDI-DI: 00841645100515
510(k) Number: K811820
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

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Properties

Sterilise before use
Lot / batch number

Other properties (13)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Prescription use: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No