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510(k) K880376

NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP by Genesis Industries, Inc. — Product Code GBS

K880376 is an FDA 510(k) premarket notification submitted by Genesis Industries, Inc. for the device "NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP". The FDA issued a decision of Substantially Equivalent on February 16, 1988. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Genesis Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1988
Date Received
January 27, 1988
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 Genesis Industries, Inc.

  • K994361 — ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO (February 18, 2000)
  • K962828 — EVERT-IT (February 10, 1997)
  • K880377 — NOVO VIVO MODEL #17140 AND #17135 (April 4, 1988)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833278 — C & B 45 (December 29, 1983)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)
  • K833285 — RX IV PENTRON IV (December 22, 1983)
  • K833288 — C & B57 PENTRON C & B57 (December 20, 1983)

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)
  • 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)
  • K863560 — URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (September 29, 1986)

FDA data resources