510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K862297Substantially Equivalent

The D & C Pad-Sac

Nu-Gyn-Tek, Inc., Oakfield NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862297 is the FDA 510(k) clearance record for THE D & C PAD-SAC, a class I device, cleared for Nu-Gyn-Tek, Inc. on under FDA product code HCY (Curette, Uterine). FDA records list 2 510(k) clearances for Nu-Gyn-Tek, Inc., from to . As of , FDA records show no recalls naming K862297.

Clearance record

Decision date
Received
(20 days to decision)
Product code
HCY Curette, Uterine
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Nu-Gyn-Tek, Inc. P.O. Box 75, Oakfield NY
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