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510(k) K811278

EXTENDED TUMOR CALIPER by Mick Radio-Nuclear Instruments, Inc. — Product Code FTY

K811278 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "EXTENDED TUMOR CALIPER". The FDA issued a decision of Substantially Equivalent on June 2, 1981. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1981
Date Received
May 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape, Measuring, Rulers And Calipers
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Mick Radio-Nuclear Instruments, Inc.

  • K230155 — Mick Valencia Applicator Set (August 30, 2023)
  • K200221 — CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Appl (February 28, 2020)
  • K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template (May 31, 2016)
  • K142597 — Vienna System (February 19, 2015)
  • K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 (December 14, 2012)
  • K063382 — HDR CT COMPATIBLE SPLIT RING APPLICATOR (December 26, 2006)
  • K063381 — CT COMPATIBLE F/S/D APPLICATORS (December 22, 2006)
  • K052351 — HDR IORT SHIELDED APPLICATOR (October 17, 2005)
  • K051423 — MICK HDR INTERSTITIAL IMPLANT ACCESSORIES (July 1, 2005)
  • K040704 — MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLI (June 18, 2004)

Other clearances for product code FTY

  • K160501 — Noxilizer Surgical Ruler (May 26, 2016)
  • K951064 — DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (May 19, 1995)
  • K934930 — OLYMPIC AUTO-LENGTH (December 29, 1993)
  • K932112 — OLYMPIC INFA-LENGTH (July 22, 1993)
  • K883485 — STRYKER PRESSURE MONITOR SYSTEM (September 13, 1988)
  • K880441 — PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (February 18, 1988)
  • K874352 — TUMORIMETER (November 23, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K872319 — LN 100 BREAST MARKER (August 11, 1987)
  • K863409 — KUNDIN WOUND GAUGE (September 29, 1986)

FDA data resources