510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081057Substantially Equivalent

Intact Breast Lesion Excision System with Intact Excision Xl

Intact Medical Corporation, Natick MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081057 is the FDA 510(k) clearance record for INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL, a class II device, cleared for Intact Medical Corporation on under FDA product code KNW (Instrument, Biopsy). FDA records list 4 510(k) clearances for Intact Medical Corporation, from to . As of , FDA records show no recalls naming K081057.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Intact Medical Corporation One Apple Hill Suite 316, Natick MA
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