Home / 510(k) Clearances / K811688

510(k) K811688

TUNGSTEN SYRINGE SHIELD by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code IWR

K811688 is an FDA 510(k) premarket notification submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging for the device "TUNGSTEN SYRINGE SHIELD". The FDA issued a decision of Substantially Equivalent on July 2, 1981. The device falls under product code IWR (Holder, Syringe, Lead), a Class I device regulated under 21 CFR 892.6500. Medi-Physics Inc. Dba Nycomed Amersham Imaging has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1981
Date Received
June 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Syringe, Lead
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging

  • K010821 — ECHOSEED/IODINE-125 SEEDS, MODEL 6733 (April 11, 2001)
  • K940632 — I-125 RAPID STRAND (September 2, 1994)
  • K921961 — SDMO APPLICATOR CODE: ASN.8236 (July 1, 1992)
  • K915156 — I-125 SEEDS CODE: 6702 (January 6, 1992)
  • K914268 — I-125 SEEDS IN CARRIER, CODE: 6720 (November 22, 1991)
  • K914281 — I-125 SEEDS, CODE: 6711 (November 22, 1991)
  • K811677 — KRYPTON CART (July 2, 1981)
  • K811118 — KRYPTON MASKS & TUBING (June 2, 1981)

Other clearances for product code IWR

  • K934549 — ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (February 19, 1994)
  • K872656 — LEAD GLASS SHIELDS (July 16, 1987)
  • K863936 — DUFFY BOLUS INJECTOR (January 6, 1987)

FDA data resources