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Peak Plasmablade 3.OS Tissue Dissection Device

by Peak Surgical, Inc.

510(k) K093695

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 · Special NumberK093695 Date13 Apr 2010ClearedStatusActive

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  • Withdrawn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 PlasBlade 3.0S Tissue Dissection Device is a radiofrequency-powered electrosurgical instrument designed for soft tissue dissection. It delivers precise, controlled pulses of energy to cut and coagulate tissue with minimal thermal spread, combining scalpel-like accuracy with hemostatic benefits.

This device is intended for use in general, plastic, and reconstructive surgical procedures, including skin incisions, flap development, and procedures in ENT, gynecology, orthopedics, arthroscopy, spinal, and neurological surgery. Supplied as a reusable instrument, it requires proper sterilization and handling per manufacturer guidelines. The device holds FDA 510(k) clearance under K093695 for electrosurgical applications.

Other devices from Peak Surgical, Inc.

Questions

AI-generated answers, 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.

  • What is the PlasBlade 3.0S Tissue Dissection Device used for?

    The PlasBlade 3.0S is a radio-powered electrosurgical instrument designed for soft tissue dissection in general, plastic, and reconstructive surgeries, including skin incisions, flap development, and procedures in ENT, gynecology, orthopedics, arthroscopy, spinal, and neurological surgery.

  • Is the PlasBlade 3.0S a single-use or reusable device?

    The PlasBlade 3.0S is supplied as a reusable instrument that requires proper sterilization and handling according to the manufacturer's guidelines.

  • What regulatory clearance does the PlasBlade 3.0S have?

    The device holds FDA 510(k) clearance under K093695 for electrosurgical applications, with a decision description of 'Substantially Equivalent' and a special clearance type.

  • How does the PlasBlade 3.0S differ from traditional electrosurgical devices?

    The PlasBlade 3.0S delivers precise, controlled pulses of energy to cut and coagulate tissue with minimal thermal spread, combining scalpel-like accuracy with hemostatic benefits.