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510(k) K844619

ENDONEEDLE by Endotherapeutics — Product Code FHO

K844619 is an FDA 510(k) premarket notification submitted by Endotherapeutics for the device "ENDONEEDLE". The FDA issued a decision of Substantially Equivalent on January 9, 1985. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Endotherapeutics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1985
Date Received
November 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pneumoperitoneum Needle
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

For establishment of a pneumoperitoneum in abdomen.

Other clearances by Endotherapeutics

  • K870855 — UROSCAN (June 9, 1987)
  • K860192 — ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE (March 17, 1986)
  • K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (February 12, 1986)
  • K860102 — MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE (February 12, 1986)
  • K852031 — ENDOPORT 5MM (August 13, 1985)
  • K841716 — ENDOPORT EROCAR (June 28, 1984)

Other clearances for product code FHO

  • K172120 — Veress Needle (September 14, 2017)
  • K121370 — VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE (August 2, 2013)
  • K010779 — MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (April 10, 2001)
  • K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE (March 27, 1997)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K951894 — ACCESS EXPANSION SYSTEM (June 15, 1995)
  • K943624 — ELMED PNEUMOPERITONEUM NEEDLES (August 10, 1994)
  • K942484 — VERRES NEEDLE (June 24, 1994)
  • K930474 — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (July 23, 1993)
  • K915725 — CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE (November 16, 1992)

FDA data resources