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510(k) K860102

MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE by Endotherapeutics — Product Code FHP

K860102 is an FDA 510(k) premarket notification submitted by Endotherapeutics for the device "MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code FHP (Needle, Pneumoperitoneum, Simple), 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
February 12, 1986
Date Received
January 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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)
  • K852031 — ENDOPORT 5MM (August 13, 1985)
  • K844619 — ENDONEEDLE (January 9, 1985)
  • K841716 — ENDOPORT EROCAR (June 28, 1984)

Other clearances for product code FHP

  • K910855 — ENDOPATH VERESS NEEDLE (April 18, 1991)

FDA data resources