510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K990913Substantially Equivalent

Hoc Set with Valve, Hoc Set without Valve, Hoc Set with Valve - Soft Plug, Hoc Set without Valve - Soft Plug, Ops Withou

Laboratoires Prodimed, Ringoes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990913 is the FDA 510(k) clearance record for HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU, a class II device, cleared for Laboratoires Prodimed on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list one 510(k) clearance for Laboratoires Prodimed. As of , FDA records show no recalls naming K990913.

Clearance record

Decision date
Received
(82 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Laboratoires Prodimed 23 Welisewitz Rd., Ringoes NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MQE

Trailing 12 months
1 clearance under product code MQE in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260