510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962771Substantially Equivalent

Burke Congenital Thoracoscopy Instruments

Pilling Weck, Inc., Fort Washington PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962771 is the FDA 510(k) clearance record for BURKE CONGENITAL THORACOSCOPY INSTRUMENTS, a class I device, cleared for Pilling Weck, Inc. on under FDA product code DWS (Instruments, Surgical, Cardiovascular). FDA records list 6 510(k) clearances for Pilling Weck, Inc., from to . As of , FDA records show no recalls naming K962771.

Clearance record

Decision date
Received
(126 days to decision)
Product code
DWS Instruments, Surgical, Cardiovascular
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Pilling Weck, Inc. 420 Delaware Dr., Fort Washington PA
510(k) summary
Summary
Third party review
No

Clearances, product code DWS

Trailing 12 months

FDA records hold no clearances under product code DWS in the trailing twelve months.

FDA records show no clearances under product code DWS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260