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510(k) K092022

TISSU TRANS HARVEST TUBING by Shippert Medical Technologies Corp. — Product Code KYZ

K092022 is an FDA 510(k) premarket notification submitted by Shippert Medical Technologies Corp. for the device "TISSU TRANS HARVEST TUBING". The FDA issued a decision of Substantially Equivalent on August 17, 2009. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Shippert Medical Technologies Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2009
Date Received
July 6, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
Submission Type

Other clearances by Shippert Medical Technologies Corp.

  • K102117 — TISSU TRANS FILTRON SYRINGE FILL (August 6, 2010)
  • K092482 — TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 (December 4, 2009)
  • K050797 — TISSU-TRANS (July 13, 2005)
  • K964855 — EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD (March 4, 1997)
  • K964334 — EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) (December 9, 1996)
  • K963704 — MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (November 26, 1996)
  • K962133 — EXPANDACELL INJECTO-PAK (August 1, 1996)
  • K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
  • K960228 — EXPANDACELL INJECTO-PAK NASAL PACK (February 27, 1996)
  • K955593 — EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (December 22, 1995)

Other clearances for product code KYZ

  • K201877 — OtoSet- Ear Cleaning System (November 5, 2020)
  • K102563 — SINGLE CANNULA EXTENDED APPLICATOR (March 15, 2011)
  • K050797 — TISSU-TRANS (July 13, 2005)
  • K991254 — QS DELIVERY SYSTEM (August 23, 1999)
  • K982435 — IRRIGATION SYRINGE KIT (November 6, 1998)
  • K974288 — ZEROWET SPLASHIELD (January 29, 1998)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K960725 — MARPP PRESSURE MONITORING SYSTEM (July 15, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)
  • K952407 — REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (August 7, 1995)

FDA data resources