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510(k) K880377

NOVO VIVO MODEL #17140 AND #17135 by Genesis Industries, Inc. — Product Code GAA

K880377 is an FDA 510(k) premarket notification submitted by Genesis Industries, Inc. for the device "NOVO VIVO MODEL #17140 AND #17135". The FDA issued a decision of Substantially Equivalent on April 4, 1988. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Genesis Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1988
Date Received
January 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
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)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833278 — C & B 45 (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 GAA

  • K223625 — CapnoSpot™ Pneumothorax Decompression Indicator (March 28, 2023)
  • K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (June 15, 2011)
  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K974741 — MANAN ACCURA NEEDLE (January 8, 1998)
  • K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (September 11, 1996)
  • K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW (July 19, 1996)
  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
  • K940024 — MANAN GENERAL PURPOSE INTRODUCER NEEDLE (February 25, 1994)

FDA data resources