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510(k) K942896

CLAMPS AND CLIPS by Surgin Surgical Instrumentation, Inc. — Product Code MDM

K942896 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "CLAMPS AND CLIPS". The FDA issued a decision of Substantially Equivalent on July 19, 1994. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Surgin Surgical Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1994
Date Received
June 20, 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 Surgin Surgical Instrumentation, Inc.

  • K082110 — DUAL SYRINGE HOLDER (June 17, 2009)
  • K033236 — PRIZM KERATOME BLADE, MODEL MK8512M2 (March 26, 2004)
  • K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (January 30, 2004)
  • K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511 (November 6, 2001)
  • K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (March 15, 2000)
  • K980849 — SURGIN KIT (July 9, 1998)
  • K954238 — SURGIN GENISIS HANDPIECE (December 8, 1995)
  • K950600 — VACUUM SURGE SUPRESSER (May 10, 1995)
  • K942945 — CASSETTE SYSTEM FOR STORZ (December 5, 1994)
  • K942944 — IRRIGATION/BIPOLAR SET (September 27, 1994)

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