Home / 510(k) Clearances / K771726

510(k) K771726

BIOSPONGE STAPES PISTON by Xomed, Inc. — Product Code JOF

K771726 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "BIOSPONGE STAPES PISTON". The FDA issued a decision of Substantially Equivalent on September 26, 1977. The device falls under product code JOF (Polymer, Ent Synthetic, Porous Polyethylene), a Class II device regulated under 21 CFR 874.3620. 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
Polymer, Ent Synthetic, Porous Polyethylene
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
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 JOF

  • K200532 — StarPore (June 2, 2020)
  • K171037 — PoreStar Patient Specific Implant (December 27, 2017)
  • K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT (February 3, 2009)
  • K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT (November 20, 2000)
  • K771727 — BIOSPONGE RECONSTRUCTION DISCS (September 26, 1977)

FDA data resources