510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946380Substantially Equivalent

Nezhat-Dorsey Reusable Aspiration-Vac Probes with and without Puncture Cannula (Hereinafter Referred to as Aspiration-V)

American Hydro-Surgical Instruments, Inc., Delray Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946380 is the FDA 510(k) clearance record for NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V), a class II device, cleared for American Hydro-Surgical Instruments, Inc. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 18 510(k) clearances for American Hydro-Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K946380.

Clearance record

Decision date
Received
(205 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
American Hydro-Surgical Instruments, Inc. 430 Commerce Dr., Delray Beach FL
510(k) summary
Summary
Third party review
No

Clearances, product code HET

Trailing 12 months

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

FDA records show no clearances under product code HET in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, 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