510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K223300Substantially Equivalent

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

Geotek Medikal Ltd Sti, Ankara, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K223300 is the FDA 510(k) clearance record for Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument, a class II device, cleared for Geotek Medikal Ltd Sti on under FDA product code KNW (Instrument, Biopsy). FDA records list 2 510(k) clearances for Geotek Medikal Ltd Sti, from to . As of , FDA records show no recalls naming K223300.

Clearance record

Decision date
Received
(176 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Geotek Medikal Ltd Sti Ivedik Osb, Agac Metal Sitesi 1436 Sk. No: 12., Ankara, TR
510(k) summary
Statement
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