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510(k) K000117

AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE by Avid Medical, Inc. — Product Code HEE

K000117 is an FDA 510(k) premarket notification submitted by Avid Medical, Inc. for the device "AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE". The FDA issued a decision of Substantially Equivalent on April 13, 2000. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. Avid Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2000
Date Received
January 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Anesthesia, Paracervical
Device Class
Class II
Regulation Number
884.5100
Review Panel
OB
Submission Type

Other clearances by Avid Medical, Inc.

  • K001731 — AVID-NIT LOSS OF RESISTANCE SYRINGE (August 29, 2000)

Other clearances for product code HEE

  • K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (October 17, 2005)
  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 3 (February 1, 1999)
  • K980238 — GYNEX EXTENDED REACH NEEDLE (August 21, 1998)
  • K973671 — ENDOCERVICAL BLOCK NEEDLE (November 26, 1997)
  • K954718 — ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE (February 29, 1996)
  • K910253 — LEEP REDIKIT (April 18, 1991)
  • K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (March 4, 1991)

FDA data resources