510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K212079Substantially Equivalent

TeesuVac Breast Biopsy Device Mark 1

Teesuvac ApS, Hoersholm, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212079 is the FDA 510(k) clearance record for TeesuVac Breast Biopsy Device Mark 1, a class II device, cleared for Teesuvac Aps on under FDA product code KNW (Instrument, Biopsy). FDA records list one 510(k) clearance for Teesuvac Aps. As of , FDA records show no recalls naming K212079.

Clearance record

Decision date
Received
(215 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Teesuvac Aps Agern Alle 3, Hoersholm, DK
510(k) summary
Summary PDF
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