510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980096Substantially Equivalent

Oac (Optical Aspirating Curette)

Imagyn Medical Technologies, Inc., Laguna Niguel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980096 is the FDA 510(k) clearance record for OAC (OPTICAL ASPIRATING CURETTE), a class I device, cleared for Imagyn Medical Technologies, Inc. on under FDA product code HCY (Curette, Uterine). FDA records list 7 510(k) clearances for Imagyn Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K980096.

Clearance record

Decision date
Received
(112 days to decision)
Product code
HCY Curette, Uterine
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Imagyn Medical Technologies, Inc. 27651 La Paz Rd., Laguna Niguel CA
510(k) summary
Summary
Third party review
No

Clearances, product code HCY

Trailing 12 months

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

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