Home / 510(k) Clearances / K965239

510(k) K965239

PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) by Accutron, Inc. — Product Code CBN

K965239 is an FDA 510(k) premarket notification submitted by Accutron, Inc. for the device "PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Accutron, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
December 31, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

Other clearances by Accutron, Inc.

  • K052335 — ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA (November 23, 2005)
  • K033503 — RFS VACUUM GAUGE SCAVENGING CIRCUIT (March 12, 2004)
  • K992421 — GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 (October 27, 1999)
  • K970046 — UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) (March 28, 1997)

Other clearances for product code CBN

  • K223452 — Nitronox Scavenger Plus (March 5, 2023)
  • K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2) (December 4, 2020)
  • K160950 — MINISCAV (May 5, 2017)
  • K142138 — ISO-GARD MASK (October 30, 2014)
  • K132729 — ISO-GARD MASK (January 9, 2014)
  • K123176 — ISO-GARD CLEARAIR MASK (February 14, 2013)
  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)
  • K092031 — VAPOR-CLEAR, MODEL 100 (April 16, 2010)
  • K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (April 14, 2008)
  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)

FDA data resources