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510(k) K920499

SANI-TIP by Dw Industries, Inc. — Product Code ECB

K920499 is an FDA 510(k) premarket notification submitted by Dw Industries, Inc. for the device "SANI-TIP". The FDA issued a decision of Substantially Equivalent on May 3, 1992. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565. Dw Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1992
Date Received
February 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 by Dw Industries, Inc.

  • K970104 — SANI-SHIELD (May 6, 1997)

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)
  • K923876 — RISKONTROL SINGLE USE (April 5, 1993)
  • K923285 — PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (September 15, 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