Home / 510(k) Clearances / K843115

510(k) K843115

STERILE SOLUTION BOWL by E.M. Adams — Product Code KDD

K843115 is an FDA 510(k) premarket notification submitted by E.M. Adams for the device "STERILE SOLUTION BOWL". The FDA issued a decision of Substantially Equivalent on September 7, 1984. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. E.M. Adams has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1984
Date Received
August 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by E.M. Adams

  • K905173 — SPLASH GUARD (April 25, 1991)
  • K910468 — STERILE DISPOSABLE DRAPE(S) (March 21, 1991)
  • K873978 — DISPOSABLE BIPOLAR FORCEPS (November 23, 1987)
  • K850063 — INSTRUMENT POCKET (February 21, 1985)
  • K843724 — I.V. START KIT & OBSTETRICAL KIT (January 10, 1985)
  • K843783 — WET PACK (December 19, 1984)
  • K843782 — DRY TRAY (December 13, 1984)
  • K843723 — STERILE INSTRUMENT TRAYS-VARIOUS (October 23, 1984)
  • K843116 — DISPOSABLE SKIN MARKING PEN (August 17, 1984)
  • K831841 — STERILE DISP. INSTRUMENT TRAYS (December 14, 1983)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources