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510(k) K923028

TURKEL PNEUMOTHORAX KIT by Symbiosis Corp. — Product Code GCB

K923028 is an FDA 510(k) premarket notification submitted by Symbiosis Corp. for the device "TURKEL PNEUMOTHORAX KIT". The FDA issued a decision of Substantially Equivalent on August 4, 1992. The device falls under product code GCB (Needle, Catheter), a Class I device regulated under 21 CFR 878.4200. Symbiosis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1992
Date Received
June 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Symbiosis Corp.

  • K955119 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 18, 1996)
  • K953453 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 17, 1996)
  • K953242 — SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES (October 6, 1995)
  • K952432 — SYMBIOSIS BIPOLAR FORCEPS (July 5, 1995)
  • K951387 — SYMBIOSIS BIPOLAR SCISSORS (April 10, 1995)
  • K950286 — SYMBIOSIS BIPOLAR SCISSORS (February 3, 1995)
  • K946238 — SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (January 20, 1995)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K941426 — SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE (June 22, 1994)
  • K932266 — SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN (March 15, 1994)

Other clearances for product code GCB

  • K150800 — Valved Safety Centesis Catheter (November 12, 2015)
  • K974146 — PARACENTESIS CATHETER DEVICE (January 28, 1998)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K900374 — ADAIR/VERESS NEEDLE INTRODUCER SET (April 20, 1990)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)

FDA data resources