510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811688Substantially Equivalent

Tungsten Syringe Shield

Medi-Physics Inc. dba Nycomed Amersham Imaging, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811688 is the FDA 510(k) clearance record for TUNGSTEN SYRINGE SHIELD, a class I device, cleared for Medi-Physics Inc. Dba Nycomed Amersham Imaging on under FDA product code IWR (Holder, Syringe, Lead). FDA records list 9 510(k) clearances for Medi-Physics Inc. Dba Nycomed Amersham Imaging, from to . As of , FDA records show no recalls naming K811688.

Clearance record

Decision date
Received
(17 days to decision)
Product code
IWR Holder, Syringe, Lead
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Medi-Physics Inc. Dba Nycomed Amersham Imaging 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IWR

Trailing 12 months

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

FDA records show no clearances under product code IWR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWR, 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