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510(k) K810485

DUJOVNY MICROSURGICAL SCISSORS by American V. Mueller — Product Code GZX

K810485 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "DUJOVNY MICROSURGICAL SCISSORS". The FDA issued a decision of Substantially Equivalent on February 27, 1981. The device falls under product code GZX (Instrument, Microsurgical), a Class I device regulated under 21 CFR 882.4525. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1981
Date Received
February 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Microsurgical
Device Class
Class I
Regulation Number
882.4525
Review Panel
NE
Submission Type

Other clearances by American V. Mueller

  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K873332 — MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM (September 8, 1987)
  • K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (June 12, 1987)
  • K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (December 29, 1986)
  • K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (August 18, 1986)
  • K861471 — V. MUELLER VITAL CLIP-HEMOSTATIC CLIP (June 6, 1986)
  • K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
  • K854049 — HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (November 27, 1985)
  • K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)

Other clearances for product code GZX

  • K932169 — MICROSURGICAL INSTRUMENTS (July 20, 1993)
  • K926048 — CLARUS ENDOSCOPIC BALL PROBE (April 7, 1993)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K873933 — RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (December 17, 1987)
  • K873934 — RANGE OF CROCODILE ACTION INSTRUMENTS (December 17, 1987)
  • K862971 — MICRA MICROSURGICAL INSTRUMENTS (August 25, 1986)
  • K853161 — THE VICKERS STANDARD MICROSURGERY SET (November 7, 1985)
  • K853179 — VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (November 7, 1985)
  • K853181 — VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (October 28, 1985)

FDA data resources