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510(k) K993445

OMNISONIC ENDOSCOPIC DEFLECTOR by Omnisonics Medical Technologies — Product Code GCM

K993445 is an FDA 510(k) premarket notification submitted by Omnisonics Medical Technologies for the device "OMNISONIC ENDOSCOPIC DEFLECTOR". The FDA issued a decision of Substantially Equivalent on December 6, 1999. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Omnisonics Medical Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1999
Date Received
October 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Omnisonics Medical Technologies

  • K083335 — MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM (December 15, 2008)
  • K071762 — OMNIWAVE ENDOVASCULAR SYSTEM (September 27, 2007)
  • K052428 — RESOLUTION ENDOVASCULAR SYSTEM (December 8, 2005)
  • K041705 — RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 (September 1, 2004)
  • K003824 — OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI (March 8, 2001)
  • K993628 — OMNISONICS ULTRASONIC PROBES (December 15, 1999)
  • K991377 — OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER (July 12, 1999)

Other clearances for product code GCM

  • K203226 — TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM (May 14, 2021)
  • K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (September 28, 2009)
  • K001217 — INSIDE VIEW (July 11, 2000)
  • K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOS (December 10, 1999)
  • K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (September 17, 1996)
  • K950712 — PORTABLE ENDOSCOPY SYSTEM (May 14, 1996)
  • K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR (January 26, 1996)
  • K935235 — ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY (March 23, 1995)
  • K945889 — KARL STORZ PLASTIC SURGERY ACCESSORIES (March 22, 1995)
  • K931954 — THORACOSCOPE/LAPAROSCOPE (November 2, 1993)

FDA data resources