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510(k) K841716

ENDOPORT EROCAR by Endotherapeutics — Product Code FBQ

K841716 is an FDA 510(k) premarket notification submitted by Endotherapeutics for the device "ENDOPORT EROCAR". The FDA issued a decision of Substantially Equivalent on June 28, 1984. The device falls under product code FBQ (Trocar, Gastro-Urology), a Class II device regulated under 21 CFR 876.5090. Endotherapeutics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1984
Date Received
April 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Gastro-Urology
Device Class
Class II
Regulation Number
876.5090
Review Panel
SU
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)
  • K860102 — MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE (February 12, 1986)
  • K852031 — ENDOPORT 5MM (August 13, 1985)
  • K844619 — ENDONEEDLE (January 9, 1985)

Other clearances for product code FBQ

  • K012198 — GIBBONS STERILE TROCAR KITS (August 9, 2001)
  • K980804 — SABRE BT BLUNT0TIP SURGICAL TROCAR (April 1, 1998)
  • K944640 — LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (October 11, 1994)
  • K944104 — GABRIS LAPAROSCOPIC SURGICAL KITS (September 13, 1994)
  • K942885 — AUTO SUTURE MODIFIED GRIP (August 22, 1994)
  • K934724 — AESCULAP TROCAR INSTRUMENT SET (December 23, 1993)
  • K904638 — TROCAR DISPOSABLE (February 21, 1991)
  • K900123 — AUTO SUTURE SURGIPORT SPIRAL SLEEVE (April 4, 1990)

FDA data resources