Home / 510(k) Clearances / K932771

510(k) K932771

BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE by Xomed-Treace, Inc. — Product Code EQH

K932771 is an FDA 510(k) premarket notification submitted by Xomed-Treace, Inc. for the device "BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on August 24, 1994. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Xomed-Treace, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1994
Date Received
June 8, 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 Xomed-Treace, Inc.

  • K940028 — ENDOSCOPE SHEATH (March 24, 1995)
  • K941407 — TYMPANOSTOMY (VENTILATION) TUBE (March 14, 1995)
  • K945659 — BLACKSTAR(TM) STAR SYSTEM (January 9, 1995)
  • K933672 — XOMED-TREACE SCOPESHEATH (July 18, 1994)
  • K934426 — NERVE INTEGRITY MONITOR-2 (NIM-2 XL) (May 13, 1994)
  • K933105 — XOMED-TREACE RIGID ROD LENS ENDOSCOPE (January 5, 1994)
  • K925640 — XOMED-TREACE EMG ENDOTRACHEAL TUBEEN (August 17, 1993)
  • K922880 — XOMED TREACE JET VENTILATION TUBE (April 15, 1993)
  • K923830 — XOMED-TREACE ALPHASCOPE (November 9, 1992)
  • K912753 — XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL (September 23, 1991)

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)
  • 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)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)
  • K923227 — THROAT-A-SCOPE (December 4, 1992)

FDA data resources