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510(k) K043358

REPROCESSED ULTRASONIC SCALPELS by Alliance Medical Corp. — Product Code NLQ

K043358 is an FDA 510(k) premarket notification submitted by Alliance Medical Corp. for the device "REPROCESSED ULTRASONIC SCALPELS". The FDA issued a decision of Substantially Equivalent on June 6, 2005. The device falls under product code NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments), a Class U device. Alliance Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2005
Date Received
December 6, 2004
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 Alliance Medical Corp.

  • K060648 — REPROCESSED PHACOEMULSIFICATION TIPS (March 19, 2007)
  • K061045 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (August 31, 2006)
  • K051438 — VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) (April 4, 2006)
  • K060049 — REPROCESSED COMPRESSION SLEEVES (February 24, 2006)
  • K060091 — ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES (February 17, 2006)
  • K053316 — REPROCESSED COMPRESSION SLEEVES (February 13, 2006)
  • K052918 — REPROCESSED EXTERNAL FIXATION DEVICES (January 27, 2006)
  • K052603 — REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS (November 16, 2005)
  • K052414 — REPROCESSED ELECTROPHYSIOLOGY CATHETER (November 16, 2005)
  • K050518 — REPROCESSED PHACOEMUISIFICATION TIPS (September 23, 2005)

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