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510(k) K903878

MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT by Mentor O & O, Inc. — Product Code HQQ

K903878 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT". The FDA issued a decision of Substantially Equivalent on November 5, 1990. The device falls under product code HQQ (Apparatus, Cautery, Radiofrequency, Battery-Powered), a Class II device regulated under 21 CFR 886.4100. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1990
Date Received
August 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Cautery, Radiofrequency, Battery-Powered
Device Class
Class II
Regulation Number
886.4100
Review Panel
OP
Submission Type

Other clearances by Mentor O & O, Inc.

  • K955245 — MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM (February 12, 1996)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K912904 — MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM (June 11, 1992)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K910637 — MENTOR(R) SUR-E-TROL(R) (May 13, 1991)
  • K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 (May 2, 1991)
  • K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (September 11, 1989)
  • K890622 — SURG-E-TROL SYSTEM I AND SYSTEM II (May 4, 1989)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)
  • K881001 — MENTOR WET-FIELD*II COAGULATOR (May 13, 1988)

Other clearances for product code HQQ

  • K910088 — SCITECH BI-MANUAL ADAPTER CLIPS (April 8, 1991)
  • K881001 — MENTOR WET-FIELD*II COAGULATOR (May 13, 1988)

FDA data resources