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510(k) K791120

MIDDLE EAR PICKS, HOOKS CURETTES, by Xomed, Inc. — Product Code GDG

K791120 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "MIDDLE EAR PICKS, HOOKS CURETTES,". The FDA issued a decision of Substantially Equivalent on July 10, 1979. The device falls under product code GDG (Hook, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1979
Date Received
June 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hook, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 GDG

  • K900069 — MODIFIED PGL ABSORBABLE STAPLE* (April 16, 1990)
  • K891898 — SKIN HOOKS, VARIOUS TYPES (April 12, 1989)
  • K864425 — RAYLOR(TM) DISSECTING HOOK (December 12, 1986)
  • K843136 — BRIMFIELD CANNULATED GRASPING HOOKS (September 25, 1984)
  • K841010 — SURGICAL HOOKS, VARIOUS (May 1, 1984)
  • K812562 — SURGICAL RETRACTOR & ELASTIC STAYS, DISP (October 2, 1981)
  • K780289 — NERVE APPROXIMATER (June 14, 1978)
  • K771187 — DERMAHOOK #382-805 (July 11, 1977)
  • K771190 — ABRAMSON TRACHEA HOOK & RETRACTOR (July 11, 1977)

FDA data resources