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510(k) K234147

ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) by Microline Surgical, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2024
Date Received
December 29, 2023
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.

  • K213127 — ReNew Disposable Scissor Tips (March 2, 2022)
  • K201884 — ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR H (October 21, 2020)
  • 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)

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