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HandX™ Monopolar Scissors

by Human Xtensions, Ltd.

510(k) K230491

HandX™ Monopolar Scissors is a Class II device made by Human Xtensions, Ltd., cleared under FDA 510(k) K230491 on 10 May 2023, active as of 26 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230491 Date10 May 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GCJ
FDA applicant
Human Xtensions , Ltd.
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K230491

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K230491
UDI-DISize and differences
Monopolar Scissors 20-30-076-01
Human Xtensions, Ltd.
20-30-076-01 / 20-30-076-0107290017376172 —On the market

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

Other devices from Human Xtensions, Ltd.

See all devices from Human Xtensions, Ltd. →