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510(k) K821697

INJECTION ASPIRATING NEEDLES by American Endoscopy, Inc. — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1982
Date Received
June 8, 1982
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 American Endoscopy, Inc.

  • K853274 — AMERICAN DILATATION SYSTEM (October 17, 1985)
  • K841384 — PROXIMA 1 PH MONITOR (July 19, 1984)
  • K833491 — ENDO BITE BLOCK (April 25, 1984)
  • K840818 — BIOPSY FORCEPS (April 13, 1984)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K833492 — PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (November 29, 1983)
  • K832458 — AUTOMATIC ENDOSCOPE (October 20, 1983)
  • K821818 — RETRIEVAL BALLOONS (September 24, 1982)
  • K821819 — PIGTAIL STENTS (August 20, 1982)
  • K822062 — BALL TIP COAGULATING ELECTRODES (August 19, 1982)

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)