510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852357Substantially Equivalent

Gyne-Shear Cervical Biopsy Instrument W/dispis Tip

Gyneco, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852357 is the FDA 510(k) clearance record for GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP, a class I device, cleared for Gyneco, Inc. on under FDA product code HFB (Forceps, Biopsy, Gynecological). FDA records list 5 510(k) clearances for Gyneco, Inc., from to . As of , FDA records show no recalls naming K852357.

Clearance record

Decision date
Received
(32 days to decision)
Product code
HFB Forceps, Biopsy, Gynecological
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Gyneco, Inc. 51 Chubb Way, Somerville NJ
Third party review
No

Clearances, product code HFB

Trailing 12 months

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

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