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510(k) K923876

RISKONTROL SINGLE USE by Riskontrol — Product Code ECB

K923876 is an FDA 510(k) premarket notification submitted by Riskontrol for the device "RISKONTROL SINGLE USE". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1993
Date Received
August 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Syringe, Air And/Or Water
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances for product code ECB

  • K942519 — UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (August 23, 1994)
  • K931772 — SURETIP SYRINGE TIP COVER (March 7, 1994)
  • K931137 — DENTAL SYRINGE TIP (November 29, 1993)
  • K923285 — PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (September 15, 1992)
  • K920499 — SANI-TIP (May 3, 1992)
  • K911756 — POSTERIOR NASAL EPISTAXIS INSTRUMENTS (October 24, 1991)
  • K890290 — BRACE (ORAFIX SPECIAL) (March 29, 1989)
  • K863024 — SERINGA TRIPLICE S.L. (September 25, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)
  • K801686 — SPACELINE THREE WAY SYRINGE (August 4, 1980)

FDA data resources