510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000117Substantially Equivalent

Avid-Nit Cervical Regional Anesthesia Needle

Avid Medical, Inc. a Medical Action Ind. Company 305, Toano VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000117 is the FDA 510(k) clearance record for AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE, a class II device, cleared for Avid Medical, Inc. on under FDA product code HEE (Set, Anesthesia, Paracervical). FDA records list 2 510(k) clearances for AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305, from to . As of , FDA records show no recalls naming K000117.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HEE Set, Anesthesia, Paracervical
Regulation
21 CFR 884.5100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Avid Medical, Inc. 9000 Westmont Dr., Toano VA
510(k) summary
Statement
Third party review
No

Clearances, product code HEE

Trailing 12 months

FDA records hold no clearances under product code HEE in the trailing twelve months.

FDA records show no clearances under product code HEE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260