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510(k) K926513

MOLLER-WEDEL OPERATING MICROSCOPE by Moeller Microsurgical, Inc. — Product Code FSO

K926513 is an FDA 510(k) premarket notification submitted by Moeller Microsurgical, Inc. for the device "MOLLER-WEDEL OPERATING MICROSCOPE". The FDA issued a decision of Substantially Equivalent on June 22, 1993. The device falls under product code FSO (Microscope, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4700. Moeller Microsurgical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1993
Date Received
December 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Moeller Microsurgical, Inc.

  • K942304 — MICROFLEX (June 13, 1994)

Other clearances for product code FSO

  • K942304 — MICROFLEX (June 13, 1994)
  • K941399 — OPERATING MICROSCOPE AA OM 10 (April 22, 1994)
  • K920689 — DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM (November 12, 1993)
  • K926288 — SOM 6VI (SURGICAL OPERATING MICROSCOPE) (October 12, 1993)
  • K931303 — WOODLYN OPERATION MICROSCOPE (June 25, 1993)
  • K910357 — SOM 6V (February 19, 1991)
  • K902076 — J2 MICROSCOPE (August 1, 1990)
  • K874241 — OPMI MD SURGICAL MICROSCOPE (December 23, 1987)
  • K822562 — ODONTO-SCOPE (October 6, 1982)
  • K822181 — BINOCULAR OPER. MICROSCOPES & ACCESSOR (August 27, 1982)

FDA data resources