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510(k) K791121

ALLIGATOR FORECPTS, CUPPED FORCEPS by Xomed, Inc. — Product Code JYR

K791121 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "ALLIGATOR FORECPTS, CUPPED FORCEPS". The FDA issued a decision of Substantially Equivalent on June 27, 1979. The device falls under product code JYR (Nipper, Malleus), a Class I device regulated under 21 CFR 874.4420. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1979
Date Received
June 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nipper, Malleus
Device Class
Class I
Regulation Number
874.4420
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 JYR

  • K822170 — INCUS NIPPERS (August 24, 1982)

FDA data resources