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510(k) K942885

AUTO SUTURE MODIFIED GRIP by United States Surgical, A Division of Tyco Healthc — Product Code FBQ

K942885 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTO SUTURE MODIFIED GRIP". The FDA issued a decision of Substantially Equivalent on August 22, 1994. The device falls under product code FBQ (Trocar, Gastro-Urology), a Class II device regulated under 21 CFR 876.5090. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1994
Date Received
June 17, 1994
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 United States Surgical, A Division of Tyco Healthc

  • K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 21, 2007)
  • K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR (September 28, 2007)
  • K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 2, 2006)
  • K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS (October 23, 2006)
  • K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE (September 1, 2006)
  • K061095 — AUTO SUTUR ENDO GIA STAPLERS (May 31, 2006)
  • K050947 — MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE (June 1, 2005)
  • K042412 — MODIFIED SPACEMAKER SYSTEM (September 24, 2004)
  • K040594 — HERCULON SOFT TISSUE REATTACHMENT SYSTEM (March 31, 2004)
  • K032696 — AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& O (December 1, 2003)

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)
  • K934724 — AESCULAP TROCAR INSTRUMENT SET (December 23, 1993)
  • K904638 — TROCAR DISPOSABLE (February 21, 1991)
  • K900123 — AUTO SUTURE SURGIPORT SPIRAL SLEEVE (April 4, 1990)
  • K841716 — ENDOPORT EROCAR (June 28, 1984)

FDA data resources