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510(k) K083508

SWABCAP by Excelsior Medical Corp. — Product Code QBP

K083508 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "SWABCAP". The FDA issued a decision of Substantially Equivalent on April 28, 2009. The device falls under product code QBP (Cap, Device Disinfectant), a Class II device regulated under 21 CFR 880.5440. Excelsior Medical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2009
Date Received
November 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Device Disinfectant
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time

Other clearances by Excelsior Medical Corp.

  • K130975 — SWABCAP AND SWABFLUSH (December 24, 2013)
  • K101270 — SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 (February 10, 2011)
  • K082837 — STERILE FIELD SALINE PRE-FILLED SYRINGE(S) (December 18, 2008)
  • K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML (February 23, 2007)
  • K053120 — STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES (December 9, 2005)
  • K023740 — SYREX PRE-FILLED SYRINGE (May 13, 2003)
  • K962938 — EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) (October 25, 1996)
  • K942349 — MICROBORE EXTENSION SET (February 8, 1995)

Other clearances for product code QBP

  • K252006 — OTTO™ Disinfecting Cap (March 27, 2026)
  • K251592 — SteriHub™ Disinfecting Device and Protective Cover (February 11, 2026)
  • K223914 — ACTIV™ Cap (April 5, 2024)
  • K193190 — BD PureHub Disinfecting Cap (November 9, 2020)
  • K200299 — Curos Jet Disinfecting Cap (October 29, 2020)
  • K192382 — CapKlenZ (April 20, 2020)
  • K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
  • K142806 — DualCap (May 22, 2015)
  • K140657 — CUROS RED PORT PROTECTOR (December 4, 2014)
  • K142399 — DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (November 19, 2014)

FDA data resources