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510(k) K905722

SUTURE APPLIER DEVICE by Laparomed Corp. — Product Code MFJ

K905722 is an FDA 510(k) premarket notification submitted by Laparomed Corp. for the device "SUTURE APPLIER DEVICE". The FDA issued a decision of Substantially Equivalent on March 14, 1991. The device falls under product code MFJ (Device, Endoscopic Suturing), a Class II device regulated under 21 CFR 876.1500. Laparomed Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1991
Date Received
December 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Endoscopic Suturing
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Other clearances by Laparomed Corp.

  • K934527 — FASCIA STITCHER (February 25, 1994)
  • K930569 — LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM (April 20, 1993)
  • K921921 — CATHETER CHOLANGIOGRAPHY (August 17, 1992)
  • K921053 — LAPAROMED LIGATING LOOP (August 6, 1992)
  • K921006 — LAPAROSCOPIC RETRACTOR SYSTEM (July 28, 1992)
  • K914066 — ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS (November 7, 1991)
  • K910074 — LAPAROMED HOOK/SPATULA DEVICE (July 2, 1991)
  • K910218 — LAPAROMED CHOLANGIOGRAM VACUUM DEVICE (April 8, 1991)
  • K910219 — LAPAROMED CHOLANGIOGRAM DEVICE (April 8, 1991)

FDA data resources