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510(k) K942818

DEEP SUTURE by Automated Medical Products Corp. — Product Code MDM

K942818 is an FDA 510(k) premarket notification submitted by Automated Medical Products Corp. for the device "DEEP SUTURE". The FDA issued a decision of Substantially Equivalent on August 25, 1994. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Automated Medical Products Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1994
Date Received
June 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Automated Medical Products Corp.

  • K942910 — DEEPVISON (July 21, 1995)
  • K942002 — RETRACTOR (May 17, 1994)
  • K940199 — DISSECTOR (March 30, 1994)
  • K832827 — CORPULS 300 (November 3, 1983)
  • K792145 — AUTOMATIC RETRACTOR HOLDERS (December 5, 1979)

Other clearances for product code MDM

  • K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (August 8, 2008)
  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (August 15, 2005)
  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (December 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)

FDA data resources