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510(k) K934510

5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD by Phx Technologies Corp. — Product Code GCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1994
Date Received
September 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esophagoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Phx Technologies Corp.

  • K974327 — WINGED NEEDLE HOLDER (January 9, 1998)
  • K971123 — STONE EXTRACTOR (June 27, 1997)
  • K954510 — RRIANGLE KNIFE (November 14, 1995)
  • K954507 — RETROGRADE KNIFE (November 14, 1995)
  • K954509 — PROBE KNIFE (November 14, 1995)
  • K954508 — RETRACTOR (November 14, 1995)
  • K954459 — CONICAL OBTURATOR (October 23, 1995)
  • K954476 — PROBE (October 23, 1995)
  • K954458 — BOAT NOSE OBTURATOR (October 23, 1995)
  • K954464 — CARPAL TUNNEL SLOTTED CANNULA (October 23, 1995)

Other clearances for product code GCL

  • K951197 — FE-24X, FIBER ESOPHAGOSCOPE (May 30, 1995)
  • K951198 — FE-34TH, FIBER ESOPHAGOSCOPE (May 30, 1995)
  • K922086 — BARD BIOPSY FORCEPS (October 30, 1992)