510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983897Substantially Equivalent

Cervical Anesthesia Needle, Contracervical Anesthesia Needle, Model #'S 720209 30Gau X 4 Mm, 720210 30Gau X 6Mm, 720208G

Ri Mos. S.r.l., Concord MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983897 is the FDA 510(k) clearance record for CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G, a class II device, cleared for Ri Mos. S.R.L. on under FDA product code HEE (Set, Anesthesia, Paracervical). FDA records list 4 510(k) clearances for Ri Mos. S.R.L., from to . As of , FDA records show no recalls naming K983897.

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
Ri Mos. S.R.L. 100 Main St., Concord MA
510(k) summary
Summary
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