Home / 510(k) Clearances / K201884

510(k) K201884

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm by Microline Surgical, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2020
Date Received
July 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Microline Surgical, Inc.

  • K234147 — ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, (April 23, 2024)
  • K213127 — ReNew Disposable Scissor Tips (March 2, 2022)
  • K160706 — ReNew V Handpiece Laparoscopic Instruments (October 19, 2016)
  • K152745 — ReNew Sterilization Trays(Catalog #3708 and #3709) (May 12, 2016)
  • K152743 — M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) (February 8, 2016)
  • K124029 — MICROLINE FLEXIBLE LIGATING SHEARS (March 27, 2013)
  • K122086 — THERMAL LIGATING SHEARS (August 23, 2012)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)