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PULSAR GENERATOR, PEAK PLASMABLADE - 4.0, Needle, And Ext Tissue Dissection Devices

by Peak Surgical, Inc.

510(k) K082786

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK082786 Date3 Dec 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1022-2011 FDA Unclassified (pre-2012) initiated 19 May 2009

    A customer reported that a patient suffered a burn while using the device.

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  • Withdrawn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
Models / Variants
4.0, Needle, And Ext Tissue Dissection Devices
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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