510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980238Substantially Equivalent

Gynex Extended Reach Needle

Gynex Corp., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980238 is the FDA 510(k) clearance record for GYNEX EXTENDED REACH NEEDLE, a class II device, cleared for Gynex Corp. on under FDA product code HEE (Set, Anesthesia, Paracervical). FDA records list 3 510(k) clearances for Gynex Corp., from to . As of , FDA records show no recalls naming K980238.

Clearance record

Decision date
Received
(210 days to decision)
Product code
HEE Set, Anesthesia, Paracervical
Regulation
21 CFR 884.5100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gynex Corp. 1000 Burnett Ave., Suite 450, Concord CA
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