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510(k) K771725

BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. by Xomed, Inc. — Product Code FEX

K771725 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.". The FDA issued a decision of Substantially Equivalent on September 26, 1977. The device falls under product code FEX (Instrument, Catheter, Punch), a Class I device regulated under 21 CFR 876.5090. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1977
Date Received
September 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Catheter, Punch
Device Class
Class I
Regulation Number
876.5090
Review Panel
GU
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 FEX

  • K911104 — PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (June 11, 1991)

FDA data resources