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510(k) K100537

REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE by Ascent Healthcare Solutions — Product Code NLQ

K100537 is an FDA 510(k) premarket notification submitted by Ascent Healthcare Solutions for the device "REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE". The FDA issued a decision of Substantially Equivalent on May 12, 2010. The device falls under product code NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments), a Class U device. Ascent Healthcare Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2010
Date Received
February 25, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single-Use Reprocessed Ultrasonic Surgical Instruments
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Ascent Healthcare Solutions

  • K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER (November 15, 2011)
  • K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT (July 18, 2011)
  • K100909 — REPROCESSED COMPRESSION SLEEVES (July 23, 2010)
  • K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (May 28, 2010)
  • K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT (March 19, 2010)
  • K093702 — REPROCESSED ULTRASONIC COAGULATING SHEARS (March 4, 2010)
  • K092425 — REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 (October 21, 2009)
  • K090323 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (April 1, 2009)
  • K082023 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (September 16, 2008)
  • K081238 — REPROCESSED MASIMO PULSE OXIMETER SENSORS (July 29, 2008)

Other clearances for product code NLQ

  • K250898 — Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter S (August 14, 2025)
  • K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocess (July 3, 2024)
  • K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocess (February 20, 2024)
  • K202554 — Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (March 16, 2021)
  • K193563 — Medline ReNewal Reprocessed Harmonic ACE+7 Shears (August 19, 2020)
  • K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (August 15, 2019)
  • K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (April 15, 2019)
  • K173627 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (July 12, 2018)
  • K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (July 3, 2017)
  • K170456 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (April 5, 2017)

FDA data resources