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510(k) K930123

ASPIRATING ENDO OCULAR PROBE by Surgical Technologies, Inc. — Product Code EQH

K930123 is an FDA 510(k) premarket notification submitted by Surgical Technologies, Inc. for the device "ASPIRATING ENDO OCULAR PROBE". The FDA issued a decision of Substantially Equivalent on February 16, 1994. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Surgical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1994
Date Received
January 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Surgical Technologies, Inc.

  • K941992 — CYSTOSCOPE (November 30, 1995)
  • K942029 — ARTHROSCOPE (November 8, 1995)
  • K946136 — INFINITECH LIGHTED INFUSION CANNULA (October 2, 1995)
  • K952566 — OSCILFLATOR (August 31, 1995)
  • K951918 — SURGICAL TECHNOLOGIES, INC. SYRINGE (July 20, 1995)
  • K950683 — ARTHROGRAM TRAY (May 6, 1995)
  • K946135 — INFINITECH ASPIRATING LASER PROBE (April 18, 1995)
  • K946181 — INFINITECH SOFT TIP FLUTE NEEDLE (March 14, 1995)
  • K942030 — BIOPSY SCISSORS (June 27, 1994)
  • K942482 — PRESSURE MONITORING EXTENSION (June 14, 1994)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)
  • K923227 — THROAT-A-SCOPE (December 4, 1992)

FDA data resources