Home / 510(k) Clearances / K930158

510(k) K930158

BONE MARROW BIOPSY PROCEDURE TRAY by Symbiosis Corp. — Product Code GAA

K930158 is an FDA 510(k) premarket notification submitted by Symbiosis Corp. for the device "BONE MARROW BIOPSY PROCEDURE TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 2, 1993. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Symbiosis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 2, 1993
Date Received
January 13, 1993
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 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 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