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Pivotal Scissor

by Urohealth Systems, Inc.

510(k) K972510

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972510 Date13 Nov 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pivotal Scissor is an electrosurgical cutting and coagulation device, classified under the General, Plastic Surgery advisory committee. It is designed for precise tissue dissection and coagulation in surgical procedures, utilising electrosurgical principles to achieve controlled cutting and sealing of soft tissues.

This device is supplied as a reusable instrument, featuring various tip configurations including scissors and dissectors. It is intended for use in operating room settings and has received FDA 510(k) clearance under the product code GEI, adhering to Class II special controls. No specific sterility or MRI safety information is provided in the available data.

Other devices from Urohealth Systems, Inc.