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510(k) K760570

ROBINSON MIDDLE EAR PROSTHESIS by Xomed, Inc. — Product Code EIB

K760570 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "ROBINSON MIDDLE EAR PROSTHESIS". The FDA issued a decision of Substantially Equivalent on September 21, 1976. The device falls under product code EIB (Syringe, Irrigating (Dental)), a Class I device regulated under 21 CFR 872.4565. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1976
Date Received
September 1, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Dental)
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code EIB

  • K911118 — DTF-1000LL,DTF-1000 (November 20, 1991)
  • K874543 — MODEL OPO-32 IRRIGATION SLEEVE (January 14, 1988)
  • K822411 — SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (July 12, 1983)

FDA data resources