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510(k) K854543

PULSE LAVAGE by Tava Surgical Instruments — Product Code FQH

K854543 is an FDA 510(k) premarket notification submitted by Tava Surgical Instruments for the device "PULSE LAVAGE". The FDA issued a decision of Substantially Equivalent on January 27, 1986. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Tava Surgical Instruments has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1986
Date Received
November 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

Other clearances by Tava Surgical Instruments

  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)
  • K940109 — TAVA K-WIRE (February 22, 1994)
  • K885273 — MICRO SURGICAL INSTRUMENT SYSTEM (January 30, 1989)
  • K884492 — MICRO SURGICAL INSTRUMENT SYSTEM (November 16, 1988)
  • K872475 — SURGICAL BUR (July 2, 1987)
  • K863788 — SAWBLADE (October 14, 1986)

Other clearances for product code FQH

  • K253996 — BD Surgiphor™ Antimicrobial Irrigation System (910110) (February 25, 2026)
  • K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (February 20, 2026)
  • K231023 — ERBEJET® 2 System (June 15, 2023)
  • K220759 — Armis VeriCyn Wound Wash (May 25, 2023)
  • K220964 — VERSAJET Hydrosurgery System (III) (May 16, 2023)
  • K221504 — BD Surgiphor™ Antimicrobial Irrigation System (October 14, 2022)
  • K222804 — Irrisept Antimicrobial Wound Lavage (September 22, 2022)
  • K210987 — IRRIGO Wound Wash Jet System (May 31, 2022)
  • K213616 — BD Surgiphor Antimicrobial Irrigation System (March 23, 2022)
  • K210536 — Irrisept Antimicrobial Wound Lavage (May 28, 2021)

FDA data resources