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510(k) K810071

STERILE SILICONE TUBING by Medspec Corp. — Product Code GBS

K810071 is an FDA 510(k) premarket notification submitted by Medspec Corp. for the device "STERILE SILICONE TUBING". The FDA issued a decision of Substantially Equivalent on February 12, 1981. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Medspec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1981
Date Received
January 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Medspec Corp.

  • K813012 — STERILE BASIN SETS (November 6, 1981)
  • K812711 — STERILE GAUZE PADS 12PLY (November 2, 1981)
  • K812707 — STERILE DISSECTOR SPONGES-X-RAY DETECT (November 2, 1981)
  • K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT (November 2, 1981)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)
  • K810069 — STERILE AIRWAY (February 2, 1981)
  • K802060 — STERILE TONSIL SPONGES (October 10, 1980)
  • K801069 — STERILE ISOLATION GOWN (May 20, 1980)
  • K801068 — STERILE ABDOMINAL PAD (May 20, 1980)
  • K800278 — MEDSPEC SAFETY PINS (May 2, 1980)

Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880895 — URESIL WOUND DRAIN TROCAR (March 14, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)

FDA data resources