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
K993936Substantially Equivalent

15Mm Siteselect Breast Biopsy Device, 10 Mm Siteselect Breast Biopsy Device, 5Mm Siteselect Breast Biopsy Device

Imagyn Surgical, Richland MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993936 is the FDA 510(k) clearance record for 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE, a class II device, cleared for Imagyn Surgical on under FDA product code KNW (Instrument, Biopsy). FDA records list 3 510(k) clearances for Imagyn Surgical, from to . As of , FDA records show no recalls naming K993936.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Imagyn Surgical 8850 M-89, Richland MI
510(k) summary
Summary
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260