510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K962077Substantially Equivalent

Bard Biopty-Cut Biopsy Needle/with Spacer

C.R. Bard Inc, Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962077 is the FDA 510(k) clearance record for BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER, a class II device, cleared for C.R. Bard, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K962077.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 129 Concord Rd., Billerica MA
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 November 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260
November 20260